FDA's June 2008 Clearances of 510(k)s

Full listing of June 2008 Clearances of 510(k)s reprinted from "The Gray Sheet" - July 21, 2008

Includes clearances for Abbott Vascular, Biomet Spine, Ethicon Endo-Surgery, Medtronic Vascular and 240 other top medical device companies. See what your competitors are doing.

FDA's June 2008 Clearances of 510(k)s

The following 510(k)s were deemed "substantially equivalent" in June. (A) Indicates an abbreviated 510(k); (S) indicates a special 510(k); ** indicates that a 510(k) summary is available from FDA; * indicates that data are available from sponsor. 510(k)s are arranged alphabetically according to sponsor. Device descriptions are derived from FDA's database.

Company
510(k) Number
Device
Decision Date

3D Line Medical Systems
K080601
Ergo++ Version 1.7**
6/6

4m Ventures Inc.
K080703
BTI Filtration Deionization Exchange Tank**
6/2

Abbott Vascular Inc.
K081417(S)
Foxcross PTA Catheter**
6/4

Accelerated Innovation, LLC
K080539
Accin Unipolar Head System**
6/2

Acheve Technology Inc.
K072861
Ceemax Slit Lamp**
6/24

Activaero America Inc.
K080100
Watchhaler**
6/30

Adroit Medical Systems Inc.
K073712
Soft Air, Model Sa 4000 and Mistral Air*
6/6

Aesculap Implant Systems
K071916
Metha Hip System**
6/2

Aesculight, LLC
K081612
Aesculight Family of Flexible Fibers, Handpieces and Tips**
6/25

Airon Corporation
K080692
Macs CPAP System**
6/20

Alfa Wassermann Diagnostic
K072140
S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test Glu**
6/24

Alfa Wassermann Diagnostic
K072141
S40 Clinical Analyzer, S Test Ip, S Test Ua**
6/24

Alfa Wassermann Diagnostic
K072142
S40 Clinical Analyzer, S Test Alp, S Test Amylase, S Test Ast**
6/26

Alfa Wassermann Diagnostic
K072356
S-Test Ca**
6/24

Alfa Wassermann Diagnostic
K073223
S-Test C02**
6/26

Alfa Wassermann Inc.
K080073
S-Test Creatinine (Cre)**
6/30

Alma Lasers, Ltd.
K072182
Alma Lasers Family of Thermo-Xel Handpieces**
6/27

Almana Medical Imaging
K080614
Dr Vision Neo, Dr Vision Dou**
6/20

Alz Inc.
K081304
Alz Web Pacs, Version 1.0**
6/11

Animas Corp.
K080639
Symphony Glucose Management System**
6/24

Ansell Healthcare Products, LLC
K080536
Micro-Touch Nitrafree**
6/19

Aribex Inc.
K081664
Nomad Pro X-Ray System**
6/23

Arkray Factory USA Inc.
K073416
Gluccocard 01 Blood Glucose Monitoring Systems**
6/13

Arrow International Inc.
K080604
Pressure Injfectable Picc**
6/27

Ascension Orthopedics Inc.
K080997
Ascension Pyrocarbon Lunate**
6/17

Avita Corporation
K081160
Avita Radar Thermo Ir Thermometer, Nt1 Series**
6/24

Axelgaard Mfg. Ltd.
K080580
Comfort Iontophoresis Electrodes/Buffered Iontophoresis Electrodes**
6/18

B. Braun Medical Inc.
K072876
Prontosan Wound Irrigation Solution**
6/19

Bausch & Lomb Inc.
K080755
Soflens Daily Disposable Toric (Hilafilcon B) Visibility Tinted lens**
6/10

Beckman Coulter Inc.
K080812
Hemoccult Ict**
6/25

Bio-Rad
K081212
Mrsaselect - Extended Incubation**
6/13

Bio-Rad
K081362
Platelia Lyme Igm**
6/26

Biocomposites, Ltd.
K081428(S)
Modification to Doubleplay Suture Anchor**
6/20

Biolase Technology Inc.
K081589(S)
Waterlase, Version 3.0**
6/13

Biomerieux Inc.
K063261
Nuclisens Easyq Enterovirus System**
6/23

Biomerieux Inc.
K080931
Vidas C. Dificile Toxin A & B (Cdab) Assay**
6/11

Biomet Manufacturing Inc.
K080088
Biomet Sports Medicine Anchor Devices and Ziploop Constructs**
6/11

Biomet Orthopedics Inc.
K080528
E-Poly Tibial Bearings**
6/17

Biomet Spine
K081395
Solitaire Peek-Optima Anterior Spinal System**
6/25

Biomet Trauma
K081243
Biomet Phoenix Ankle Nail System**
6/27

Biomet Inc.
K080330
Segmental Distal Femoral Components and Proximal Femoral Bodies**
6/11

Bioretec, Ltd.
K080879
Activatm Product Group Including Bioabsorbable Devices Activapin**
6/24

Bioretec, Ltd.
K081392(S)
Bioretec Activascrew**
6/18

Biosite Inc.
K080269
Triage Cardioprofiler and Profiler S.O.B. Panels**
6/6

Bk Meditech, Ltd.
K080876
Dvx Spine System**
6/4

Bonesupport AB
K073316
Cerament Bone Void Filler, Model A0210**
6/20

Brainlab AG
K080678
Uni-Knee 2.0**
6/6

Brainlab AG
K080886
Iplan Rt Image**
6/24

Brainlab AG
K080888(S)
Modification To Iplan Rt Dose**
6/11

C.R. Bard Inc.
K073598
Bard Dignicare Stool Management System**
6/13

C.R. Bard Inc.
K081311(S)
Powerport Implanted Port with Groshong Catheter**
6/4

Caire Inc.
K080023(S)
Modification to Spirit**
6/16

Candela Corp.
K081324(S)
Candela Family of Q-Switched Alexandrite Lasers**
6/17

Canon Inc.
K081648
Digital Radiography Cxdi-60g**
6/24

Civco Medical Instruments
K080072
MRI Patient Positioning Devices**
6/4

Cliniqa Corporation
K080973
Cliniqa Liquid QC Complete Cardiac Marker Control*
6/2

CMA Microdialysis AB
K071984
Modification to CMA Cerebral Tissue Monitoring System**
6/27

Co-Ligne AG
K072326
Ostapek Vbr System**
6/24

Concentric Medical Inc.
K081305(S)
Merci Retriever**
6/5

Conmed Corporation
K081580
Beamer Argon Snare Probe**
6/19

Conmed Corporation
K081634
Conmed Goldvac Integrated Smoke Evacuation Pencil**
6/25

Cousin Biotech S.A.S.
K072962
Cabs'air**
6/26

Creaspine
K081564(S)
Creaspine Supstance Vertebral Body Replacement System Line Extension**
6/30

Cryocath Technologies Inc.
K081049(S)
Flexcath Steerable Sheath & Dilator**
6/27

Cure Medical, LLC.
K080881
Cure Catheter Closed System**
6/11

Dade Behring Inc.
K071597
Dimension Vista Afp Flex Reagent Cartridge**
6/4

Dade Behring Inc.
K071603
Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge**
6/25

Datascope Corp.
K080175(A)
Navigator Anesthesia Delivery System, Model 0998-00-3024-01**
6/9

Depuy Orthopaedics Inc.
K081620(S)
Modification to Depuy Delta Xtend Reverse Shoulder System**
6/30

Depuy Spine Inc.
K080828(S)
Mountaineer Oct Spinal System**
6/27

Derma Sciences Canada
K080497
Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver**
6/27

Derma Sciences Inc.
K081584
Derma Sciences Otc Medihoney Dressings with Active Manuka Honey**
6/19

Diagnostic Hybrids Inc.
K081164
D3 Dfa Cytomegalovirus Immediate Early Antigen Identification Kit**
6/13

Dockstader Orthodontic Lab
K072731(A)
Endsnor**
6/12

Dornier Medtech America
K080959
Dornier Medilas D 30 Laser, Medilas D 1064**
6/27

Duckworth & Kent, Ltd.
K072985
Duckworth & Kent, Ltd. Injector, Model: Dk7797-2**
6/20

Ekos Corp.
K081467(S)
Ekosonic Endovascular System with Rapid Pulse Modulation**
6/26

Elekta, Ltd.
K080585
Desktop Pro**
6/11

Endogastric Solutions Inc.
K073644
Endogastric Solutions Stomaphyx Device and Accessories**
6/27

Entellus Medical Inc.
K081542(S)
Modification to Entellus Medical Rs-Series System**
6/27

Ergometa
K080146
Zirkondent*
6/6

Ethicon Endo-Surgery
K073288
Ethicon Endo Surgery Articulating Snare**
6/12

Ethicon Endo-Surgery
K081146
Echelon Endoscopic Linear Cutters (Articulating and Straight)**
6/26

Falck Medical Inc.
K071755
Falck Applanation Tonometer (Fat2)**
6/3

Feel Tech
K080904
Feel-Fine Insulin Pen Needle**
6/4

Flowcardia Inc.
K080765
Crosser Lp System**
6/20

Foosin Medical Supplies Inc.
K080684
Wg-Surgical Sutures with Needle**
6/9

Freedom Sciences, LLC
K073330
Freedom Sciences Motion Control Module**
6/20

Fujifilm Medical Systems U.S.A.
K081308(S)
Fujifilm Fcr View, Model Cr-Vw674**
6/4

Fujirebio Diagnostics Inc.
K072939
He4 Eia, Model: 404-10 US**
6/9

G Surgical, Ltd.
K081041
Gps, G Surgical Pedicle System**
6/27

Gambro Renal Products Inc.
K080519
Prismaflex M150 Set**
6/13

Gc America Inc.
K080478
Gradia Forte*
6/5

Gc America Inc.
K080724
Gc Opb-100*
6/11

GE Healthcare
K081091
Precision 500d R&F X-Ray System**
6/11

GE Medical Systems
K080251
Apexpro Telemetry Systems**
6/20

GE Medical Systems
K081496
Discovery Xr and Xa Diagnostic Imaging Systems**
6/12

Genesis Biosystems Inc.
K081578
Accela System**
6/20

Hamilton Medical AG
K080181
Modification to Galileo Gold**
6/24

Hansen Medical Inc.
K073225
Sensei Catheter Control System**
6/30

Herniamesh S.R.L.
K081327
Relimesh**
6/19

Hitachi Medical Systems America
K081198
Echelon Rapid Head Coil, Model Mr-Rhc-150n, Echelon Rapid Torso**
6/18

Howmedica Osteonics Corp.
K081044(S)
Rejuvenate Modular Hip System**
6/3

Howmedica Osteonics Corp.
K081152(S)
T2 Femoral Nail**
6/10

I.T.S. Implantat-Technologie-Systeme
K080706
Connexx Locking Tibia Nail**
6/9

Imacor, LLC
K080223
Zura Tee System**
6/24

Intact Medical Corporation
K081057
Intact Breast Lesion Excision System**
6/17

Integra Luxtec Inc.
K081477
Luxtec Mlx Light Source*
6/18

Intel Corp.
K080798(A)
Intel Health Guide, Model: Phs6000**
6/27

International Biomedical, Ltd.
K081399(S)
Aviator Transport Incubator*
6/6

Invivo Corporation
K081262
Dc Neuro**
6/17

Irhythm Technologies Inc.
K081471
Ecard and Ccard*
6/24

Itamar Medical
K081037(S)
Watch-Pat 200i (Wp200i)**
6/9

Ivu Imaging Corporation
K080555
Sofia Automated Tomographic Ultrasound (Atus)**
6/3

K2m Inc.
K081381(S)
Range Spinal System, Large Denali Screws**
6/13

Kaltenbach & Voigt, GmbH
K080677
Comfortronic 4894 and Comfortdrive 200xda Handpiece**
6/6

Kimberly-Clark Corp.
K081027(A)
Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)**
6/30

Kiscomedica S.A.
K080537
L-Varlock**
6/30

Kronus Market Development
K080523
Kronus Blocking Acetylcholine Receptor Autoantibody (Achrab) Ria*
6/17

Kwang Yang Motor, Ltd.
K081133
Kymco Foru, Model Eq40**
6/10

Lazarus Medical, LLC
K073702
Phoneris Inner Cannulae with Phoneris Aero-Flex**
6/26

Levitronix, LLC.
K081221
Levitronix Centrimag Primary Console, Thoratec Centrimag Primary**
6/19

Lifescan Inc.
K081318(S)
Onetouch Zoom Diabetes Management Program**
6/9

Lorenz Biotech S.P.A.
K080902(A)
Frems Ssc Disposable Foam Electrodes, Model 800-000-057**
6/13

Luminex Molecular Diagnostics Inc.
K081483(S)
Xtag Respiratory Viral Panel**
6/25

Lutronic Corporation
K080932(S)
Mosaic Laser System**
6/9

Mac Medical
K080609
Swc/Dwc Warming Cabinets**
6/13

Mako Surgical Corp.
K080368
Mako Surgical Unicondylar Knee Implant System II**
6/20

Maquet Critical Care AB
K073179
Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option**
6/9

Martin Manufacturing, LLC
K080506(A)
Martin Chair, Model C4s1**
6/9

Med-Dyne
K080112
Patient Cable*
6/20

Medi Nuclear Corp. Inc.
K080657
Neb-90 Large Volume Medication Nebulizer**
6/30

Medical Predictive Science Corp.
K081473(S)
Hero, Version 2.0**
6/27

Medpro Safety Products Inc.
K072602(A)
Vacuette Premium Safety Needle System**
6/18

Medrad Inc.
K080297
Medrad Intego Pet Infusion System**
6/17

Medtronic Sofamor Danek
K081297(S)
Vertex Reconstruction System**
6/11

Medtronic Sofamor Danek
K062254
Axis Fixation System**
6/16

Medtronic Vascular
K081573(S)
Medtronic Export Ap Catheter**
6/27

Medxpert, GmbH
K073556
Medxpert P.E.S. (Pectus Exacvatum System), Medxpert Stratos**
6/24

Mennen Medical, Ltd.
K081484(S)
Horizon Xvu**
6/20

Meta Biomed, Ltd.
K080772
Bonemedik-Dm**
6/3

Micrus Endovascular Corporation
K080379
Micrus Microcoil System, Deltapaq 10 Stretch Resistant**
6/30

Minos Medical
K080550
Megachannel Endoscopic Overtube, Model Ot22**
6/10

New Medical, Ltd.
K080589(S)
Saturn 9000-810**
6/11

New Star Lasers Inc.
K081628(S)
Modification to Cooltouch**
6/20

Next Mobility, LLC
K081665
Millenium II**
6/27

Nilimedix, Ltd.
K070844
Nilimedix Adi**
6/6

Nonin Medical Inc.
K081285(S)
Finger Pulse Oximeter, Model 9560**
6/5

Olympic Medical Corp.
K081094(S)
Olympic Pasteurmatic, Models 3000 and 3500**
6/20

Optical Imaging, Ltd.
K080180
Modification to Retinal Function Imager (Rfi)**
6/11

Orqis Medical Corporation
K073631
Orqis Extracorporeal Blood Pumping System, Model Bps-100**
6/27

Ortho-Clinical Diagnostics
K081411(S)
Vitros Chemistry Product Na+ Slides**
6/30

Orthopediatrics, LLC
K081097
Orthopediatrics Pediflex Flexible Nail System**
6/3

Orthovita Inc.
K081439(S)
Vitoss Bioactive Foam Pack Bone Graft Substitute**
6/17

Oscor Inc.
K081052
Occlusion Balloon Catheter, Model Venos*
6/18

Pajunk, GmbH Medizintechnologie
K080675
Pajunk Infiltralong Wound Infiltration Catheter Kit**
6/20

Palomar Medical Products Inc.
K080244
Palomar Lux 1540 Handpiece**
6/20

Perry Baromedical Corp.
K072427(A)
Sigma Series Hyperbaric Chamber**
6/11

Philips Medical Systems(Cleveland)
K081426
Nexstar Liftoff Pet Application Software Suite**
6/4

Philips Ultrasound Inc.
K081661
Hd15 Diagnostic Ultrasound System**
6/24

Pioneer Surgical Technology
K073229(A)
Nerve Monitoring Cable**
6/6

Plasma Surgical, Ltd.
K080197
Plasmajet Neutral Plasma Surgery System**
6/24

Possis Medical Inc.
K081454(S)
Guarddog Occlusion Guidewire, Inflation Device**
6/13

Precision Surgery, Ltd.
K073708(S)
Fixed, Variable & Corpectomy Cervical Plate System**
6/3

Procter & Gamble
K081555(S)
Tampax Pearl Plastic Applicator Tampons, Scented and Unscented**
6/27

Quest Diagnostics Inc.
K080381
Quest Diagnostics Methamphetamine Micro-Plate Eia**
6/25

Remgenic, LLC
K080516
Lamin Air**
6/23

Respironics Novametrix, LLC
K080652(S)
Mercury Vco2 Module with Capnostat 5**
6/20

Richard Wolf Medical Instruments
K080617
Power Drive Art1 2304 with Motor Handles, Tools and Accessories**
6/27

Rnk Products Inc.
K081032
Tr-Usb Telephonic Stethoscope**
6/6

Roche Diagnostics Corp.
K073501
Roche Elecsys Toxo IgG Test System, Roche Elecsys Precicontrol**
6/9

Roche Diagnostics Corp.
K080811
Tina-Quant Cystatin C, Calibrator F.A.S. Cystatin C**
6/20

Rti Biologics Inc.
K081538(S)
Tutopatch, Tutomesh**
6/19

S.S. White Burs Inc.
K080687
Smartburs*
6/20

Sandstone Medical Technologies
K081219
Apollo Mini Ipl System**
6/30

Sectra Imtec AB
K081469(S)
Sectra Workstation, Ids7 Version 11.3, Ids5 Version 11.1 P2**
6/12

Sentinel Ch. Spa
K073634
Multigent Creatinine (Enzymatic) Assay**
6/19

Sentinel Ch. Spa
K081533
Sentinel Plasmaproteins Cal 3x**
6/25

Shanghai Chenguang Medical
K081322
Magnetic Resonance Diagnostic Device, Model 0100140201**
6/18

Shanghai Chenguang Medical
K081340
Pediatric Body and Cardiac Coil, Model 01000140201**
6/18

Sharps Compliance Inc.
K073577
Sharps Transport Tube, Model 50035*
6/23

Shenzhen Mindray Bio-Medical
K073280
Beneview T Series Patient Monitors, Models T8, T6 and T5**
6/23

Shofu Dental Corp.
K080517
Resicem*
6/11

Shofu Dental Corp.
K080834
Vintage Art*
6/11

Siemens Medical Solutions
K073537
Neonatal Bilirubin On Rapidlab Models 1245 and 1265**
6/27

Siemens Medical Solutions
K081022
Somatom Definition, Model as/as+**
6/2

Siemens Medical Solutions
K081453
Biograph Hd Family**
6/23

Siemens Medical Solutions
K081121
Modification to Acuson X150 Ultrasound System**
6/4

Signus Medizintechnik, GmbH
K081332(S)
Athlet Vertebral Body Replacement System**
6/10

Sintea Biotech Inc.
K072198
X-Void, Spider**
6/6

Smith & Nephew Inc.
K072852
Sl-Plus Standard and Lateral Hip Stems**
6/9

Smith & Nephew Inc.
K081106(S)
Peri-Loc Periarticular Locked Plating System Volar Distal Radius**
6/18

Smith & Nephew Inc.
K081491(S)
Smith & Nephew Cds System**
6/19

Smiths Medical Asd Inc.
K072080
Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129**
6/2

SSL Americas Inc.
K072169(A)
Durex Synthetic Polyisoprene Male Condom**
6/19

Stelkast Company
K081458(S)
Proven Stem Extender*
6/6

Steris Corporation
K081427(S)
Browne Opa Test Strip**
6/11

Storz Medical AG
K072809
D-Actor Vibration Massage System**
6/27

Stryker Spine
K080773
Thor Anterior Plating System**
6/9

Superdimension, Ltd.
K081379(S)
Modification to Inreach System**
6/11

Surgicraft, Ltd.
K073109(A)
Stalif Tt Intervertebral Body Fusion System**
6/4

Surgicraft, Ltd.
K080447
Surgicraft Screw Fixation System**
6/13

Sutures India Pvt., Ltd.
K081001
Pd Synth, Absorbable (Poly Dioxanone) Suture**
6/9

Sutures India Pvt., Ltd.
K081002
Monoglyde, Absorbable (Poliglecaprone 25) Suture**
6/9

Sutures India Pvt., Ltd.
K081003
Trusynth, Absorbable (Polyglactin 910) Suture**
6/9

Taidoc Technology Corporation
K080014
Clever Chek Td-3250c Blood Glucose Plus Blood Pressure Monitoring**
6/9

Taidoc Technology Corporation
K080283
Ideal Life Gluco-Manager Gmm 0001 Blood Glucose Monitoring System**
6/27

Taidoc Technology Corporation
K081144(S)
Clever Chek Auto-Code Voice Blood Glucose Monitoring System*
6/23

Teikoku Pharma USA Inc.
K072560
Envela (Hydrohesive Occlusive Dressing)**
6/17

Teleflex Medical Inc.
K080230
Neb-U-Mask System, Models 1895, 1896**
6/9

Terumo Cardiovascular Systems Corp
K080034
Three Stage Venous Return Cannula, Model 816460**
6/17

The Binding Site, Ltd.
K080384
Human Cystatin C Kit for Use On Modular P Analyser*
6/6

Theken Spine, LLC
K081414(S)
Modification to Coral Spinal System**
6/17

Thompson Surgical Instruments Inc
K080962
Lite Wand II**
6/25

Titan Spine, LLC
K080615
Endoskeleton Ta Interbody Fusion Device (Ibd)**
6/17

Tokotu Electric, Ltd.
K081242
21.3 Inch (53cm) Monochrome Digital Mammography Lcd Monitor Ms51**
6/11

Tokuyama Dental Corporation
K080940
Estelite Sigma Quick**
6/19

Toshiba America Medical Systems
K081065
Aplio Xg Diagnostic Ultrasound System, Model Ssa - 790a**
6/6

Toshiba America Medical Systems
K081482
Csbp-001a Body Organ Perfusion System**
6/11

Toshiba America Medical Systems
K081582
Infx-8000v, Infinix-Cfi and Infinix Vfi**
6/17

Toshiba America Medical Systems
K081621
Infx-8000c (Infinix Cc-I and Vc-I)**
6/23

Toshiba America Medical Systems
K081624
Infx-8000f (Infinix Csi and Infinix Dpi)**
6/23

Totoku Electric, Ltd.
K081055
21.3" (54cm) 2m Color Lcd Monitor Ccl254i2 (Cdl2125a)**
6/4

Totoku Electric, Ltd.
K081056
21.3" (54cm) 3M Color Lcd Monitor Ccl354i2 (Cdl2126a)**
6/4

Traumacure Inc.
K081183
Woundstat**
6/19

Tyson Bioresearch Inc.
K072854
Diachex Basic Blood Glucose Monitoring System*
6/30

Ultimed Inc.
K080600
Ultimed Ulticare Safety Syringe**
6/25

Ultimed Inc.
K081449
Ultiguard Home Insulin Pen Needle Dispenser and Sharps Container**
6/3

US Spine
K081296(S)
Preference Pedicle Screw System**
6/6

Ushifu Development Company, LLC
K080970
Ushifu Stepper**
6/11

Velocity Medical Solutions, LLC
K081076(S)
Velocityais, Velocity Ai, Velocityvx, Velocityrt, V-Response**
6/20

Vertebral Technologies Inc.
K080673
Interfuse Intervertebral Body Fusion Device**
6/10

Vesticon
K071973
Epley Omniax**
6/20

Viasys Healthcare, GmbH
K080734
Flowscreen, Flowscreen/Corscreen, Flowscreen Ct**
6/26

Viasys Medsystems
K080679
Modification to Cortrak Enteral Access Device*
6/27

Villa Sistemi Medicali S.P.A.
K080859
Drf 4343**
6/4

Vision Systems Group
K081585(S)
Endoscopy Video Camera System**
6/20

Visual Footcare Technologies, LLC
K080816
Visual Footcare Technologies Tempstat**
6/24

Vitalograph(Ireland), Ltd.
K073155
Vitalograph Model 4000 (Asma-1 and Copd-6)**
6/4

Well-Life Healthcare Limited
K080304
Pro TENS, Model Wl-240 Rx**
6/20

Widex Hearing Aid Inc.
K080955
Zen Program (Mind 440 Hearing Aid)**
6/27

Ya Horng Electronic, Ltd.
K081590
Ya Horng Arm Type Digital Blood Pressure Monitor**
6/19

Zefon International
K080366(A)
Duracheck Blood Pressure Cuff, Model Zdc4000 Series*
6/9

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