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 2005-04-05

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM

Applicant Health & Life Co., Ltd.

K number K050587

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DXN 2005-04-05

OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M

Applicant Omron Healthcare, Inc.

K number K042506

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DXN 2005-04-05

OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N

Applicant Omron Healthcare, Inc.

K number K042505

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DXN 2005-03-31

H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF

Applicant Health & Life Co., Ltd.

K number K050491

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DXN 2005-03-31

GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR

Applicant Gocanning Technology , Ltd.

K number K043352

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DXN 2005-03-30

HL168JP

Applicant Health & Life Co., Ltd.

K number K050249

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DXN 2005-03-30

MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR

Applicant Mars Medical Products

K number K050040

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DXN 2005-03-25

MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR

Applicant Nihon Seimitsu Sokki Co., Ltd.

K number K050697

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DXN 2005-03-25

MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR

Applicant Mars Medical Products

K number K050039

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DXN 2005-03-21

KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

Applicant Kodon(Tianjin)Electronic&Electrical Apparatus Co.,

K number K042418

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DXN 2005-03-09

DIASYS INTEGRA II

Applicant Novacor France

K number K042109

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DXN 2005-03-04

AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600

Applicant Amplife Corporation

K number K050413

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DXN 2005-03-03

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

Applicant A&D Engineering, Inc.

K number K043217

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DXN 2005-02-22

MEDICOMPASS CONNECT

Applicant Imetrikus, Inc.

K number K042768

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DXN 2005-01-27

AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100

Applicant Amplife Corporation

K number K043550

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DXN 2005-01-27

PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037

Applicant Matsushita Electric Works, Ltd.

K number K042818

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DXN 2005-01-12

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET

Applicant Health & Life Co., Ltd.

K number K043437

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DXN 2004-12-10

VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR

Applicant Mars Medical Products Co., Ltd.

K number K032825

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DXN 2004-12-06

H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM

Applicant Health & Life Co., Ltd.

K number K043186

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DXN 2004-12-03

A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512

Applicant A&D Engineering, Inc.

K number K042967

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DXN 2004-12-02

WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES

Applicant Hangzhou Hua'An Medical & Health Instruments Co.,

K number K041693

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DXN 2004-11-24

COMMANDER II

Applicant Cardiocom

K number K043096

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DXN 2004-11-10

OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906

Applicant Omron Healthcare, Inc.

K number K043018

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DXN 2004-11-10

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA

Applicant Health & Life Co., Ltd.

K number K042853

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DXN 2004-10-26

H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J & HL168Q

Applicant Health & Life Co., Ltd.

K number K042802

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DXN 2004-10-13

AMLUCK, YA HORNG

Applicant Ya Horng Electronic Co., Ltd.

K number K042581

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DXN 2004-10-06

MPM SYSTEM

Applicant Aerotel Medical Systems, Ltd.

K number K041854

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DXN 2004-09-20

ZEWA MFM-007 BLOOD PRESSURE MONITOR

Applicant Zewa, Inc.

K number K041491

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DXN 2004-08-31

MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY

Applicant Health Hero Network, Inc.

K number K042273

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DXN 2004-08-31

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888

Applicant Health & Life Co., Ltd.

K number K042265

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DXN 2004-08-31

REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T

Applicant Maxi-Aids, Inc.

K number K041778

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DXN 2004-08-31

LIFECLINIC, MODEL 2400

Applicant Lifeclinic International, Inc.

K number K040562

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DXN 2004-08-24

FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311

Applicant Sein Electronics Co., Ltd.

K number K042138

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DXN 2004-08-24

FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01

Applicant Fortifier International Co., Ltd.

K number K041400

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DXN 2004-08-24

PIESOMETER, MODEL MK-1

Applicant Canamet Canadian Natl Medical Technologies, Inc.

K number K041169

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DXN 2004-08-18

HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS

Applicant Hommed, LLC

K number K040799

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DXN 2004-08-18

WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE

Applicant Welch Allyn, Inc.

K number K040490

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DXN 2004-08-10

HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM

Applicant Hommed, LLC

K number K040651

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DXN 2004-08-06

DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400

Applicant Sein Electronics Co., Ltd.

K number K042014

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DXN 2004-07-21

MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP

Applicant Microlife Corp.

K number K041411

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DXN 2004-07-15

NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T

Applicant Meditec Co., Ltd.

K number K041789

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DXN 2004-06-18

STABIL-O-GRAPH

Applicant I.E.M. GmbH

K number K041313

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DXN 2004-05-19

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

Applicant A&D Engineering, Inc.

K number K040371

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DXN 2004-05-17

MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200

Applicant Mytech Technology Co., Ltd.

K number K041228

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DXN 2004-05-12

VERICOR

Applicant Cvp Diagnostics, Inc.

K number K031327

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DXN 2004-05-07

FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR

Applicant Sein Electronics Co., Ltd.

K number K032927

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DXN 2004-05-05

GREENLIGHT 300

Applicant A C Cossor & Son (Surgical) Limited

K number K040410

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DXN 2004-05-04

BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR

Applicant The Buzz Group, LLC

K number K033216

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DXN 2004-04-15

AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T

Applicant Ya Horng Electronic Co., Ltd.

K number K040528

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DXN 2004-04-09

AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY

Applicant Avita Corporation

K number K033397

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DXN 2004-04-02

WELL@HOME SYSTEM

Applicant Zoe Medical, Inc.

K number K040012

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DXN 2004-03-22

APM BLOOD PRESSURE MONITOR, MODEL BP108A

Applicant Asia Pacific Microsystems, Inc.

K number K040159

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DXN 2004-03-22

MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1

Applicant Microlife Intellectual Property Gmb

K number K040002

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DXN 2004-03-22

MODEL AVANT 2120 PULSE OXIMETER AND NIBP

Applicant Nonin Medical, Inc.

K number K031487

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DXN 2004-03-19

A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328

Applicant A&D Engineering, Inc.

K number K040229

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DXN 2004-03-11

PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032

Applicant Matsushita Electric Works, Ltd.

K number K033894

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DXN 2004-03-10

HEALTH BUDDY WITH BUDDYLINK

Applicant Health Hero Network, Inc.

K number K040086

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DXN 2004-02-27

CENTRAL STATION, VERSION 3.3H

Applicant Hommed, LLC

K number K040032

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DXN 2004-02-24

DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862

Applicant Nihon Seimitsu Sokki Co., Ltd.

K number K040309

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DXN 2004-02-11

OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL

Applicant Omron Healthcare, Inc.

K number K032305

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DXN 2004-02-04

PRESS-MATE BX-10 VITAL SIGN MONITOR

Applicant Colin Medical Instruments Corp.

K number K032857

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DXN 2003-12-10

TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700

Applicant Tytan Medical Corp.

K number K033025

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DXN 2003-11-10

BLOOD PRESSURE MONITOR, MODEL M100

Applicant Meditek Technology, Inc.

K number K032308

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DXN 2003-11-06

KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

Applicant Kodon(Tianjin)Electronic&Electrical Apparatus Co.,

K number K030359

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DXN 2003-10-31

ZOLL M SERIES NIBP OPTION

Applicant Zoll Medical Corp

K number K032363

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DXN 2003-10-31

KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

Applicant Kodon(Tianjin)Electronic&Electrical Apparatus Co.,

K number K030358

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DXN 2003-10-30

A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS

Applicant A&D Engineering, Inc.

K number K032499

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DXN 2003-10-23

FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1

Applicant Fms, Finapres Medical Systems BV

K number K023723

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DXN 2003-10-10

MODIFICATION TO HL168

Applicant Health & Life Co., Ltd.

K number K033043

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DXN 2003-10-10

HL888BA

Applicant Health & Life Co., Ltd.

K number K032839

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DXN 2003-10-10

HL888BM

Applicant Health & Life Co., Ltd.

K number K032837

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DXN 2003-10-10

CAREMATIX WELLNESS SYSTEM

Applicant Carematix, Inc.

K number K031840

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DXN 2003-10-02

HL888 AF

Applicant Health & Life Co., Ltd.

K number K032913

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DXN 2003-10-02

HL888BF

Applicant Health & Life Co., Ltd.

K number K032695

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DXN 2003-09-09

BLOOD PRESSURE MONITOR, MODEL KP-7000

Applicant K-Jump Health Co., Ltd.

K number K032492

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DXN 2003-09-05

BPCARD

Applicant Qrs Diagnostic, LLC

K number K031964

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DXN 2003-07-25

MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR

Applicant Mytech Technology Co., Ltd.

K number K030221

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DXN 2003-07-01

HL888RA

Applicant Health & Life Co., Ltd.

K number K031835

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DXN 2003-07-01

HL168R

Applicant Health & Life Co., Ltd.

K number K031695

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DXN 2003-06-06

AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506

Applicant Datex-Ohmeda, Inc.

K number K031479

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DXN 2003-06-06

GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100

Applicant Genteel Technology Co., Ltd.

K number K022926

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DXN 2003-05-23

AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)

Applicant Avita Corporation

K number K030230

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DXN 2003-05-09

MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A

Applicant Mytech Technology Co., Ltd.

K number K030561

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DXN 2003-05-09

PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2

Applicant Fms, Finapres Medical Systems BV

K number K023338

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DXN 2003-05-02

CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION

Applicant Neptec Design Group, Ltd.

K number K023286

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DXN 2003-04-24

HL888JF

Applicant Health & Life Co., Ltd.

K number K030541

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DXN 2003-04-17

HL888HM

Applicant Health & Life Co., Ltd.

K number K030499

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DXN 2003-04-11

HL888HA

Applicant Health & Life Co., Ltd.

K number K030498

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DXN 2003-03-28

MPM-NET

Applicant Aerotel Medical Systems (1998) , Ltd.

K number K030825

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DXN 2003-03-21

BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR

Applicant Vsm Medtech , Ltd.

K number K023078

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DXN 2003-03-10

DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR

Applicant Zewa, Inc.

K number K024077

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DXN 2003-02-12

WELCH ALLYN VITAL SIGN MONITOR WITH MP506

Applicant Welch Allyn, Inc.

K number K024005

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DXN 2003-01-14

HL888

Applicant Health & Life Co., Ltd.

K number K023834

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DXN 2002-12-12

OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC

Applicant Omron Healthcare, Inc.

K number K021682

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DXN 2002-11-21

BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211

Applicant K-Jump Health Co., Ltd.

K number K022916

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DXN 2002-11-19

TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM

Applicant Tensys Medical, Inc.

K number K022783

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DXN 2002-11-08

EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200

Applicant Eikon Healthcare Device Corp.

K number K021240

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DXN 2002-11-08

EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M

Applicant Eikon Healthcare Device Corp.

K number K021239

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DXN 2002-10-31

WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)

Applicant Welch Allyn, Inc.

K number K023495

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DXN 2002-10-22

BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200

Applicant Vsm Medtech , Ltd.

K number K023055

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