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 1999-03-29

ADVANCED NIBP MODULE

Applicant Johnson & Johnson Medical, Inc.

K number K982641

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DXN 1999-03-25

BCI MINI-TORR PLUS, MODEL 6004

Applicant Bci Intl., Inc.

K number K984618

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DXN 1999-03-05

AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300

Applicant Nihon Seimitsu Sokki Co., Ltd.

K number K981702

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DXN 1999-03-03

PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284

Applicant Panasonic Corporation (Panasonic)

K number K981542

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DXN 1999-03-03

PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280

Applicant Panasonic Corporation (Panasonic)

K number K981431

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DXN 1999-03-02

ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL

Applicant Industrielle Entwicklung Medizintechnik Und Vertri

K number K964235

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DXN 1999-02-22

(1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250; (2) FULLY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL MD-700

Applicant Meditec Co., Ltd.

K number K990380

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DXN 1999-01-22

6004 NIBP MONITOR WITH TEMPERATURE

Applicant Bci Intl., Inc.

K number K983796

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DXN 1998-12-14

MS-900S, MS-900SPM & MS-900SFM

Applicant Mars Medical Products

K number K980845

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DXN 1998-11-17

FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F

Applicant Jawon Medical Co., Ltd.

K number K983855

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DXN 1998-09-25

A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR

Applicant A&D Engineering, Inc.

K number K982481

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DXN 1998-09-25

PRESS-MATE ADVANTAGE

Applicant Colin Medical Instruments Corp.

K number K973637

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DXN 1998-09-15

OSCILLOMATE EMS NIBP MONITOR MODEL 9001

Applicant Cas Medical Systems, Inc.

K number K982135

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DXN 1998-06-11

ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000

Applicant Rossmax International , Ltd.

K number K964153

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DXN 1998-04-14

CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER

Applicant Foley & Lardner

K number K973613

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DXN 1998-03-19

A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR

Applicant A&D Engineering, Inc.

K number K980824

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DXN 1998-03-13

CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B)

Applicant Citizen Watch Co., Ltd.

K number K973061

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DXN 1998-02-20

CARDIO-CARD MANAGEMENT SYSTEM II

Applicant Nasiff Assoc., Inc.

K number K972795

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DXN 1998-01-16

RECHARGEABLE BATTERY PART NUMBER GL825-200

Applicant Alexander Mfg. Co.

K number K974061

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DXN 1998-01-02

TANGO NON-INVASIVE BLOOD PRESSURE MONITOR

Applicant Suntech Medical Instruments, Inc.

K number K970629

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DXN 1997-11-12

BCI MODEL 6004 NIBP MONITOR (6004)

Applicant Bci Intl., Inc.

K number K970801

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DXN 1997-04-01

CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER

Applicant Citizen Watch Co., Ltd.

K number K954547

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DXN 1997-03-12

MS-2000

Applicant Touritu Engineering Co., Inc.

K number K961144

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DXN 1997-02-11

AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION

Applicant Advance Medical Device, Inc.

K number K964697

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DXN 1996-11-14

FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000

Applicant Sein Electronics Co., Ltd.

K number K952827

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DXN 1996-11-14

FULL AUTO FUZZY BLOOD PRESSURE METER MODEL SE-7000

Applicant Sein Electronics Co., Ltd.

K number K952826

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DXN 1996-09-09

PERSONAL TELEMEDICINE SYSTEM

Applicant American Telecare, Inc.

K number K952882

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DXN 1996-07-25

HANC NETWORK

Applicant Healthtech Services Corp.

K number K952979

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DXN 1996-07-02

A & D UB-302 WRIST DIGITAL BLOOD PRESSURE MONITOR

Applicant A&D Engineering, Inc.

K number K960319

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DXN 1996-06-17

OMRON, LUMISCOPE, LABTRON, MEDI - SOURCE, BAXTER

Applicant Rashman Corp.

K number K955342

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DXN 1996-03-13

CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1

Applicant Tycos Instruments, Inc.

K number K951193

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DXN 1996-01-31

MARS DIGITAL BLOOD PRESSURE MONITOR

Applicant Mars Metal Co., Ltd.

K number K945215

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DXN 1995-12-28

DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR

Applicant Nihon Seimitsu Sokki Co., Ltd.

K number K952494

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DXN 1995-11-20

OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS

Applicant Invivo Research, Inc.

K number K945138

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DXN 1995-10-24

DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883

Applicant Integrated Display Technology, Ltd.

K number K951977

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DXN 1995-10-20

NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR

Applicant Nellcor, Inc.

K number K953472

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DXN 1995-07-14

ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS

Applicant Sankei Co., Ltd.

K number K942543

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DXN 1995-06-23

DYNAPULSE 5000A (DP5000A)

Applicant Pulse Metric, Inc.

K number K945111

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DXN 1995-05-10

MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND

Applicant Mabis Healthcare, Inc.

K number K942072

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DXN 1995-03-08

NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER

Applicant Nellcor, Inc.

K number K945947

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DXN 1995-02-15

NAIS WRIST BLOOD PRESSURE METER

Applicant King & Spalding

K number K942423

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DXN 1995-02-15

PANASONIC WRIST BLOOD PRESSURE METER

Applicant King & Spalding

K number K942422

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DXN 1995-02-01

VASOTRAC BLOOD PRESSURE MONITOR, MODEL - APM 205

Applicant Medwave, Inc.

K number K950249

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DXN 1995-01-27

TRIMLINE 2000

Applicant Pymah Corp.

K number K943081

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DXN 1995-01-27

CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER

Applicant Dynatech/Nevada, Inc.

K number K942546

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DXN 1994-12-20

WINNER SELF-TAKING HOME BLOOD PRESSURE KIT

Applicant Winmed Instruments Mfg. Corp.

K number K942163

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DXN 1994-11-29

MINIMUS I; MINIMUS III, SANAPHON

Applicant Rud Riester GmbH & CO KG

K number K942649

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DXN 1994-11-29

BLOOD PRESSURE METER MODEL NO. BPM888

Applicant Integrated Display Technology, Ltd.

K number K941490

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DXN 1994-11-28

AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR

Applicant Integrated Display Technology, Ltd.

K number K942336

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DXN 1994-11-14

NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553)

Applicant Spacelabs Medical, Inc.

K number K941167

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DXN 1994-10-17

PRESS-MATE BP8800MS AUTOMATIC NON-INVASIVE BLOOD PRESSURE SYSTEM

Applicant Colin Medical Instruments Corp.

K number K942871

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DXN 1994-08-15

BIG BEN

Applicant Rud Riester GmbH & CO KG

K number K942650

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DXN 1994-08-10

MINIPACK 3100/3000 MODIFICATION

Applicant Pace Tech, Inc.

K number K934385

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DXN 1994-08-01

ROSSMAX INTERNATIONAL LIMITED ACCURACY BLOOD PRESSURE MONITOR

Applicant Quality Systems Design, Inc.

K number K940620

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DXN 1994-08-01

DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES

Applicant Ohmeda Medical

K number K935782

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DXN 1994-07-27

VARIOUS TYPES OF MERCURIALS

Applicant Rud Riester GmbH & CO KG

K number K943461

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DXN 1994-03-25

EXACTA-SPEZIAL

Applicant Rudolf Riester GmbH & Co. KG

K number K925295

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DXN 1994-02-23

PRECISA

Applicant Rudolf Riester GmbH & Co. KG

K number K925294

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DXN 1994-02-17

BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK

Applicant Portable Power Systems, Inc.

K number K932823

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DXN 1994-01-24

NAMTAI

Applicant Nam Tai Electronics (Canada) , Ltd.

K number K935872

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DXN 1993-12-29

NAMTAI

Applicant Nam Tai Electronics (Canada) , Ltd.

K number K935652

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DXN 1993-12-03

PROFILOMAT

Applicant Qmed, Inc.

K number K932109

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DXN 1993-10-07

ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR

Applicant Citizen Watch Co., Ltd.

K number K923344

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DXN 1993-09-17

OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 9300

Applicant Cas Medical Systems, Inc.

K number K925402

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DXN 1993-07-01

SYSTEM 7110 NON-INVASIVE BLOOD PRESSURE MONITOR

Applicant Advanced Medical Instruments, Inc.

K number K923595

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DXN 1993-07-01

BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST

Applicant Colin Medical Instruments Corp.

K number K921048

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DXN 1993-07-01

CRITIKON VITAL SIGNS MODULE

Applicant Critikon Company, LLC

K number K915697

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DXN 1993-05-13

OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT.

Applicant Omron Healthcare, Inc.

K number K930798

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DXN 1993-05-13

SYSTEM 7500 NIBP/SA02

Applicant Advanced Medical Instruments, Inc.

K number K924910

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DXN 1992-12-24

OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601

Applicant Omron Healthcare, Inc.

K number K920778

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DXN 1992-12-23

OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706

Applicant Omron Healthcare, Inc.

K number K914823

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DXN 1992-11-20

NAMTAI ELECTRONIC BLOOD PRESSURE METER

Applicant Nam Tai Electronics (Canada) , Ltd.

K number K924210

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DXN 1992-11-06

SIEMENS NP NONINVASIVE BLOOD PRESS MEASUREMENT SYS

Applicant Siemens Medical Electronics

K number K914765

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DXN 1992-11-03

DIGITAL BLOOD PRESSURE MONITOR MODEL #UF-101

Applicant Showa Engineering Co., Ltd.

K number K921627

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DXN 1992-10-09

BP PUMP

Applicant Bio-Tek Instruments, Inc.

K number K921074

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DXN 1992-10-09

NIBP 9225 COMBI

Applicant S & W Medico Teknik

K number K912815

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DXN 1992-09-22

MODEL P-81 CRITIKON PRINTER

Applicant Critkon, Inc.

K number K915468

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DXN 1992-09-04

4240 DYNAMIC BP/HEART RATE MONITOR

Applicant Suntech Medical Instruments, Inc.

K number K914260

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DXN 1992-07-14

ACCUTRACKER DX

Applicant Suntech Medical Instruments, Inc.

K number K913844

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DXN 1992-03-27

DS-240 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM

Applicant Koven and Assoc., Inc.

K number K913595

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DXN 1992-03-04

NGM NIBP MODULE

Applicant Datex Division Instrumentarium Corp.

K number K911645

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DXN 1992-01-22

OSCILLOMATE (TM) BLOOD PRESSURE MONITOR-MODEL 1630

Applicant Cas Medical Systems, Inc.

K number K911722

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DXN 1991-12-19

AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS

Applicant Sein Electronics Co., Ltd.

K number K912588

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DXN 1991-11-07

CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS

Applicant Cardiodyne, Inc.

K number K911871

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DXN 1991-11-06

AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR

Applicant Omron Healthcare, Inc.

K number K913523

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DXN 1991-10-28

ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR

Applicant Citizen Watch Co., Ltd.

K number K911965

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DXN 1991-09-10

CASIO BP-100

Applicant Casio, Inc.

K number K910643

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DXN 1991-09-05

CARDIOCAP II(TM)

Applicant Datex Medical Instrumentation, Inc.

K number K912530

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DXN 1991-08-22

BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP

Applicant Biochem International, Inc.

K number K911351

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DXN 1991-08-07

DIGITAL SPHYGMOMANOMETER MODEL UB-211 AND 212

Applicant A&D Engineering, Inc.

K number K912119

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DXN 1991-08-07

DIGITAL SPHYGMOMANOMETER MODEL UA-833

Applicant A&D Engineering, Inc.

K number K912118

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DXN 1991-08-07

DIGITAL SPHYGMOIMANOMETER, MODEL UA-830

Applicant A&D Engineering, Inc.

K number K911049

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DXN 1991-07-17

CARDIOCAP CMX-104 MONITOR

Applicant Datex Division Instrumentarium Corp.

K number K903237

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DXN 1991-06-21

EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR

Applicant Medi-Swiss Corp.

K number K904298

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DXN 1991-06-10

COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD

Applicant Ge Medical Systems Information Technologies

K number K911310

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DXN 1991-04-12

PROPAQ 102, 104 AND 106

Applicant Protocol Systems, Inc.

K number K910772

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DXN 1991-03-06

E-20 RAPID CUFF INFLATOR

Applicant D. E. Hokanson, Inc.

K number K905367

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DXN 1991-02-19

HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE

Applicant Hewlett-Packard Co.

K number K903771

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DXN 1991-01-18

OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C

Applicant Omron Marshall Products, Inc.

K number K903133

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DXN 1991-01-08

DYNAPULSE 200M

Applicant Pulse Metric, Inc.

K number K904739

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