System, Measurement, Blood-Pressure, Non-Invasive

FDA product code DXN · 1166 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1130
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-09 – 2026-09-10

DXN 2002-09-13

DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11

Applicant Digibio Technology Corp.

K number K014141

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DXN 2002-08-15

TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM

Applicant Tensys Medical, Inc.

K number K020537

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DXN 2002-08-06

ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400

Applicant Rossmax Internationl , Ltd.

K number K020897

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DXN 2002-07-09

VP-2000/1000

Applicant Colin Corp.

K number K013434

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DXN 2002-06-28

MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER

Applicant Microlife Corp.

K number K021305

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DXN 2002-06-27

WELCH ALLYN ABPM 6100

Applicant Welch Allyn, Inc.

K number K021756

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DXN 2002-06-17

BLOOD-PRESSURE METER

Applicant Idt Technology Limited

K number K021252

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DXN 2002-05-22

TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM

Applicant Aerotel Medical Systems (1998) , Ltd.

K number K021447

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DXN 2002-05-22

ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I

Applicant Rossmax International , Ltd.

K number K021225

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DXN 2002-05-22

N2000 BASE STATION; N2001 NURSE STATION

Applicant Neptec Design Group, Ltd.

K number K020584

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DXN 2002-04-22

HOMMED CENTRAL STATION

Applicant Hommed, LLC

K number K020184

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DXN 2002-04-12

ABP-2000 G-3

Applicant Biotrac, Inc.

K number K021029

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DXN 2002-04-05

HL168F

Applicant Health & Life Co., Ltd.

K number K020766

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DXN 2002-03-14

AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000

Applicant Amluck, Inc.

K number K012796

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DXN 2002-03-05

ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822

Applicant K-Jump Health Co., Ltd.

K number K014204

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DXN 2002-02-21

SPHYGMOCOR PX MODEL SCOR-PX

Applicant Atcor Medical Pty, Ltd.

K number K012487

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DXN 2002-02-15

A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS

Applicant A&D Engineering, Inc.

K number K012472

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DXN 2002-01-23

VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)

Applicant Vasocor, Inc.

K number K011625

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DXN 2002-01-17

ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS

Applicant Rossmax International , Ltd.

K number K013583

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DXN 2002-01-17

ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS

Applicant Rossmax International , Ltd.

K number K013539

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DXN 2002-01-17

MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1

Applicant Microlife Corp.

K number K013485

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DXN 2002-01-16

HL168E

Applicant Health & Life Co., Ltd.

K number K014122

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DXN 2002-01-10

DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM

Applicant Pulse Metric, Inc.

K number K013478

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DXN 2001-12-13

DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM

Applicant Pulse Metric, Inc.

K number K013358

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DXN 2001-11-14

N2000 BASE STATION, N2001 NURSE STATION

Applicant Neptec Design Group, Ltd.

K number K012801

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DXN 2001-11-09

TONOPORT V

Applicant Par Medizintechnik GmbH

K number K012647

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DXN 2001-11-01

DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM

Applicant Pulse Metric, Inc.

K number K012498

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DXN 2001-10-26

BPTRU AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100

Applicant Vsm Technology, Inc.

K number K012636

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DXN 2001-10-23

MODIFICATION TO: HL168W TOUCH SCREEN

Applicant Health & Life Co., Ltd.

K number K013033

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DXN 2001-10-23

TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII

Applicant Meridian Medical Technologies , Ltd.

K number K011058

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DXN 2001-08-22

MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR

Applicant Health & Life Co., Ltd.

K number K012310

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DXN 2001-08-08

FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312

Applicant Sein Electronics Co., Ltd.

K number K012054

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DXN 2001-07-27

BRAUN PRECISION SENSOR PRO, MODEL BP 2590

Applicant Braun GmbH

K number K012035

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DXN 2001-07-20

ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS

Applicant Rossmax International , Ltd.

K number K011539

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DXN 2001-07-20

ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS

Applicant Rossmax International , Ltd.

K number K011352

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DXN 2001-07-20

NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1

Applicant Nien Made Electrnics Corp.

K number K011310

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DXN 2001-07-13

LIFESOURCE MODELS UA-787, UA 787PC, UA-787T

Applicant A&D Engineering, Inc.

K number K012013

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DXN 2001-07-13

AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM

Applicant Avid Care Corp.

K number K011779

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DXN 2001-06-29

HOME HEALTH MONITORING SYSTEM

Applicant Avid Care Corp.

K number K010029

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DXN 2001-06-28

HOMMED OBSERVER, MODEL I

Applicant Hommed, LLC

K number K003180

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DXN 2001-06-14

ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138

Applicant Rossmax International , Ltd.

K number K011523

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DXN 2001-06-11

BPFONE, MODEL UA 767IT

Applicant Medical Monitors Pty Limited

K number K010751

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DXN 2001-06-08

WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM

Applicant Welch Allyn, Inc.

K number K010186

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DXN 2001-05-31

VASOTRAC APM205A

Applicant Medwave, Inc.

K number K011152

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DXN 2001-05-16

BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES

Applicant Braun GmbH

K number K003732

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DXN 2001-03-29

DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP

Applicant A&D Engineering, Inc.

K number K010828

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DXN 2001-03-29

PRESSURE TRAK, MODEL 222-B

Applicant Suntech Medical Instruments, Inc.

K number K010622

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DXN 2001-03-20

WRISTWATCH BLOOD PRESSURE MONITOR A46

Applicant Rossmax Internationl , Ltd.

K number K010498

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DXN 2001-03-19

WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120

Applicant K-Jump Health Co., Ltd.

K number K002665

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DXN 2001-02-08

WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43

Applicant Rossmax Internationl , Ltd.

K number K010190

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DXN 2001-01-29

NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM

Applicant Unix Electronic Co. , Ltd.

K number K002791

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DXN 2001-01-29

BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520

Applicant Welch Allyn, Inc.

K number K001543

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DXN 2000-12-15

AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P

Applicant Sein Electronics Co., Ltd.

K number K003711

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DXN 2000-11-21

MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR

Applicant Nihon Seimitsu Sokki Co., Ltd.

K number K003444

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DXN 2000-11-14

WELCH ALLYN SPOT CHECK DEVICE

Applicant Welch Allyn, Inc.

K number K002530

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DXN 2000-11-01

FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H

Applicant Sein Electronics Co., Ltd.

K number K003282

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DXN 2000-11-01

CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM

Applicant Hypertension Diagnostics, Inc.

K number K001948

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DXN 2000-10-25

OSCAR 2, MODEL 222

Applicant Suntech Medical Instruments, Inc.

K number K003004

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DXN 2000-10-13

HL168B

Applicant Health & Life Co., Ltd.

K number K002882

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DXN 2000-09-26

BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D

Applicant Citizen Watch Co., Ltd.

K number K001244

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DXN 2000-09-21

DINAMAP PRO 1000 MONITOR, MODEL 1000

Applicant Critikon Company, LLC

K number K002248

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DXN 2000-09-21

ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION

Applicant Zoll Medical Corp

K number K002029

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DXN 2000-09-18

HL168T

Applicant Health & Life Co., Ltd.

K number K002750

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DXN 2000-09-11

DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505

Applicant Jawon Medical Co., Ltd.

K number K002722

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DXN 2000-09-06

DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550

Applicant Meditec Co., Ltd.

K number K002655

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DXN 2000-08-31

VASOTRAX

Applicant Medwave, Inc.

K number K001898

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DXN 2000-08-25

EHC500 DESKTOP PATIENT STATION, MODEL EHC500

Applicant Cybercare, Inc.

K number K002388

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DXN 2000-08-01

MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1

Applicant Microlife Corp.

K number K001182

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DXN 2000-07-25

A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS

Applicant A&D Engineering, Inc.

K number K002115

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DXN 2000-07-21

MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100

Applicant Vsm Technology, Inc.

K number K002046

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DXN 2000-07-03

OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907

Applicant Omron Healthcare, Inc.

K number K001848

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DXN 2000-06-30

ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630

Applicant Omron Healthcare, Inc.

K number K001671

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DXN 2000-06-30

AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757

Applicant Omron Healthcare, Inc.

K number K001670

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DXN 2000-06-13

EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION

Applicant Cybercare, Inc.

K number K000237

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DXN 2000-06-09

UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE

Applicant Ueda Avancer Corp.

K number K993316

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DXN 2000-05-26

DINAMAP ADVANCED NIBP MODULE

Applicant Critikon Company, LLC

K number K000500

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DXN 2000-04-10

MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254

Applicant Matsushita Electric Corp. of America

K number K991458

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DXN 2000-03-28

AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100

Applicant Vsm Medtech , Ltd.

K number K994423

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DXN 2000-03-15

THE HOMMED SENTRY, MODEL 1 SENTRY

Applicant Hommed, LLC

K number K993938

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DXN 2000-03-14

MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502

Applicant Jawon Medical Co., Ltd.

K number K000675

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DXN 2000-01-18

MULTIFUNCTION KEITO K5

Applicant Bumedco Intl., Inc.

K number K984083

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DXN 2000-01-11

ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43

Applicant Rossmax International , Ltd.

K number K993460

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DXN 2000-01-07

ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40

Applicant Rossmax International , Ltd.

K number K993429

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DXN 2000-01-07

ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44

Applicant Rossmax International , Ltd.

K number K993426

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DXN 1999-12-29

ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46

Applicant Rossmax International , Ltd.

K number K993542

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DXN 1999-12-20

A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS

Applicant A&D Engineering, Inc.

K number K993888

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DXN 1999-12-20

ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46

Applicant Rossmax International , Ltd.

K number K993432

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DXN 1999-12-03

HL148 & HL168

Applicant Health & Life Co., Ltd.

K number K990807

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DXN 1999-12-01

DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181

Applicant Nihon Seimitsu Sokki Co., Ltd.

K number K993890

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DXN 1999-10-15

PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A

Applicant Hewlett-Packard, Healthcare Solutions Group

K number K992478

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DXN 1999-10-15

DAIWA MODEL 180

Applicant Daiwa Products, Inc.

K number K983616

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DXN 1999-10-07

ANEROID SPHYGMOMANOMETER

Applicant Genmed, Inc.

K number K990638

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DXN 1999-09-16

BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM

Applicant Aerotel Medical Systems (1998) , Ltd.

K number K983717

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DXN 1999-09-01

A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE

Applicant A&D Medical Div.

K number K992808

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DXN 1999-09-01

NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM

Applicant Physio-Control Corp.

K number K990338

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DXN 1999-08-10

KELLER VITAL SIGNS MONITOR, KMS 890+

Applicant Keller Medical Specialties Products, Inc.

K number K990648

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DXN 1999-07-21

FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800

Applicant Meditec Co., Ltd.

K number K992328

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DXN 1999-06-01

WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S

Applicant Jawon Medical Co., Ltd.

K number K991688

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DXN 1999-05-13

ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX

Applicant Datascope Corp.

K number K983575

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DXN 1999-04-28

BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471

Applicant Citizen Watch Co., Ltd.

K number K984223

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