Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Electrocardiograph

FDA product code DPS · 558 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.2340
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-19 – 2026-09-25

DPS 2004-04-06

HRV TOOLS

Applicant Del Mar Reynolds Medical, Ltd.

K number K040313

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DPS 2003-10-31

AUDICOR UPGRADE SYSTEM

Applicant Inovise Medical, Inc.

K number K032145

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DPS 2003-10-03

ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH

Applicant Remco Italia S.P.A.

K number K032200

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DPS 2003-08-01

CARDIODIRECT, MODELS 12M, 12I, 12S

Applicant Reynolds Medical , Ltd.

K number K024283

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DPS 2003-07-25

ELI 200+ AUDICOR

Applicant Mortara Instrument, Inc.

K number K031182

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DPS 2003-07-03

PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291

Applicant Philips Medical Systems

K number K031422

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DPS 2003-06-11

EKGCARD SYSTEM

Applicant Qrs Diagnostic, LLC

K number K030535

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DPS 2003-06-11

PRIME ECG SYSTEM

Applicant Meridian Medical Technologies, Inc.

K number K030104

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DPS 2003-05-29

PACEART SYSTEM

Applicant Medtronic Vascular

K number K024278

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DPS 2003-05-09

HERO

Applicant Medical Decision Networks

K number K021230

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DPS 2002-09-06

X-SCRIBE II

Applicant Mortara Instrument, Inc.

K number K022618

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DPS 2002-07-16

HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS

Applicant Cambridge Heart, Inc.

K number K022152

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DPS 2002-07-16

CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000

Applicant Cambridge Heart, Inc.

K number K022149

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DPS 2002-05-29

MICRO-INDUCTION 1000 SYSTEM

Applicant Harbinger Medical, Inc.

K number K013615

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DPS 2002-05-08

Q-STRESS ECHO BED

Applicant Medical Positioning, Inc.

K number K021171

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DPS 2002-04-30

GLOBAL ECG MANAGEMENT SYSTEM (GEMS)

Applicant Cardiocomm Solutions, Inc.

K number K020366

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DPS 2002-04-25

PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES

Applicant Philips Medical Systems, Inc.

K number K020708

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DPS 2002-03-26

COSMED QUARK C12/QUARK T12

Applicant Cosmed Srl

K number K014262

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DPS 2002-03-06

PRIME ECG SYSTEM

Applicant Meridian Medical Technologies, Inc.

K number K012414

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DPS 2002-02-06

BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY

Applicant Brentwood Medical Technology Corp.

K number K013717

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DPS 2001-12-13

CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH

Applicant Reynolds Medical , Ltd.

K number K013367

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DPS 2001-12-13

CAIRD TECHNOLOGY HOLTER 2000

Applicant Caird Technology

K number K012686

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DPS 2001-11-21

CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000

Applicant Cambridge Heart, Inc.

K number K013565

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DPS 2001-11-21

MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS

Applicant Cambridge Heart, Inc.

K number K013564

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DPS 2001-10-10

MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC

Applicant National Custom Ent., Inc.

K number K012264

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DPS 2001-10-10

MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024

Applicant National Custom Ent., Inc.

K number K012263

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DPS 2001-09-26

BLY-501 ADAPTOR

Applicant Micromedical Industries, Ltd.

K number K012540

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DPS 2001-07-05

MOBILE-PATIENT VIEWER

Applicant Data Critical Corporation

K number K011436

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DPS 2001-05-23

BCI ADVISOR VITAL SIGNS MONITOR (9200)

Applicant Bci, Inc.

K number K011177

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DPS 2001-04-26

BMT ANSCORE HEALTH MANAGEMENT SYSTEM

Applicant Boston Medical Technologies, Inc.

K number K010955

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DPS 2001-04-18

AB CARDIETTE START 200 HV

Applicant H&C Medical Devices Spa

K number K010822

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DPS 2001-04-12

HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS

Applicant Cambridge Heart, Inc.

K number K010758

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DPS 2001-03-09

TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY

Applicant Brentwood Medical Technology Corp.

K number K010505

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DPS 2001-01-31

VERTEX SYSTEM

Applicant Medical Positioning, Inc.

K number K002822

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DPS 2001-01-25

CARDIO MONITOR CENTER VISION; MODEL S-CV7-00

Applicant Shl Telemedicine International , Ltd.

K number K003392

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DPS 2001-01-08

KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC

Applicant Suzuken Co., Ltd.

K number K001896

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DPS 2000-12-27

CARTOUCH

Applicant Cardionics, Inc.

K number K002197

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DPS 2000-11-08

WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES

Applicant Nihon Kohden America, Inc.

K number K002473

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DPS 2000-11-08

PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH

Applicant Agilent Technologies, Inc.

K number K002459

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DPS 2000-10-04

AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES

Applicant H&C Medical Devices Spa

K number K002074

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DPS 2000-08-11

BMT ANSCORE HEALTH MANAGEMENT SYSTEM

Applicant Boston Medical Technologies, Inc.

K number K993875

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DPS 2000-08-09

QUINTON Q-STRESS, MODEL 000483

Applicant Quinton, Inc.

K number K001492

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DPS 2000-06-09

MODEL APS ALTERNANS PROCESSING SYSTEM

Applicant Cambridge Heart, Inc.

K number K001034

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DPS 2000-05-24

GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11

Applicant General Electric Medical Systems Information Techn

K number K000645

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DPS 2000-04-07

PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2

Applicant Prucka Engineering, Inc.

K number K993414

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DPS 1999-11-18

MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION

Applicant General Electric Medical Systems Information Techn

K number K991786

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DPS 1999-06-11

BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1

Applicant Boston Medical Technologies, Inc.

K number K991831

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DPS 1998-12-03

MONITOR ONE NDX

Applicant Qmed, Inc.

K number K972991

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DPS 1998-10-14

CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM

Applicant Cambridge Heart, Inc.

K number K981697

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DPS 1998-08-25

MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE

Applicant Micromedical, Inc.

K number K974220

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DPS 1998-08-19

CARDIOVISION SOFTWARE, MODEL S-CV5-96

Applicant Shl Telemedicine International , Ltd.

K number K981807

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DPS 1998-08-12

ANS 2000 ECG MONITOR AND RESPIRATION PACER

Applicant D. E. Hokanson, Inc.

K number K973426

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DPS 1998-08-05

CT 200 ELECTROCARDIOGRAPH

Applicant Macquarie Medical Systems

K number K961798

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DPS 1998-07-28

CT 100 ELECTROCARDIOGRAPH

Applicant Macquarie Medical Systems

K number K981951

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DPS 1998-06-30

MRI COMPATIBLE MONITOR AND ACCESSORIES

Applicant Datex-Engstrom, Inc.

K number K980362

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DPS 1998-04-28

EASY ECG PC BASED ELECTROCARDIOGRAPH

Applicant Ates Medical S.R.L.

K number K972996

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DPS 1998-04-01

BIOLOG 3000 ELECTROCARDIOGRAPH

Applicant Micromedical, Inc.

K number K974351

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DPS 1998-03-18

M1765A ECG MANAGER

Applicant Hewlett-Packard Co.

K number K974746

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DPS 1998-03-11

ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B

Applicant Dr. Lee Co., Ltd.

K number K972603

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DPS 1998-01-22

FORMULA FOR ARCHIMED

Applicant Biosound Esaote, Inc.

K number K974079

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DPS 1997-12-03

HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES

Applicant Hewlett-Packard GmbH

K number K973437

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DPS 1997-10-21

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100

Applicant Alexander Mfg. Co.

K number K972746

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DPS 1997-09-25

SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS

Applicant Marquette Electronics, Inc.

K number K972199

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DPS 1997-09-24

KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE

Applicant Kontron Instruments , Ltd.

K number K971038

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DPS 1997-08-20

NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH

Applicant Nihon Kohden America, Inc.

K number K972310

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DPS 1997-08-13

SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)

Applicant Quinton, Inc.

K number K964784

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DPS 1997-07-23

POSEIDON CARDIAC MONITORING SYSTEM (PCMS)

Applicant Instromedix, Inc.

K number K964408

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DPS 1997-06-30

PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)

Applicant Intl. Products, Inc.

K number K963578

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DPS 1997-05-14

ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)

Applicant Alexander Mfg. Co.

K number K970787

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DPS 1997-03-05

PS-41 6M PATIENT SIMULATOR

Applicant Metron U.S., Inc.

K number K963198

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DPS 1996-11-26

NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER

Applicant Nellcor Puritan Bennett, Inc.

K number K963400

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DPS 1996-10-23

AS/3 LIGHT MONITOR

Applicant Datex Division Instrumentarium Corp.

K number K961247

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DPS 1996-10-08

HP CATHSTATION - MODEL M1264B

Applicant Hewlett-Packard Co.

K number K961401

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DPS 1996-10-08

CARDIOVIEW TRANSTELEPHONIC SOFTWARE

Applicant Micromedical, Inc.

K number K955891

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DPS 1996-08-28

MEDILOG STRESSLINK

Applicant Oxford Medical, Inc.

K number K951128

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DPS 1996-08-21

CARDIOCATH CATHETERIZATION LAB SYSTEM

Applicant Prucka Engineering, Inc.

K number K960321

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DPS 1996-08-16

PATIENT MONITOR MODEL 405P

Applicant Ivy Biomedical Systems, Inc.

K number K955546

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DPS 1996-08-15

DINAMAP SELECT MULTI-PARAMETER SYSTEM

Applicant Johnson & Johnson Medical, Inc.

K number K955113

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DPS 1996-07-15

CARDIMAX MODEL FX-2111

Applicant Fukuda Denshi USA, Inc.

K number K955416

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DPS 1996-07-11

OMNI-TRAK PATIENT MONITORING SYSTEM

Applicant Invivo Research, Inc.

K number K955045

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DPS 1996-07-02

NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER

Applicant Nellcor Puritan Bennett, Inc.

K number K955642

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DPS 1996-05-30

PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)

Applicant Biosensor Corp.

K number K960449

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DPS 1996-05-13

CARDIOSMART

Applicant Hellige GmbH

K number K950989

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DPS 1996-02-29

CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM

Applicant Cambridge Heart, Inc.

K number K950018

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DPS 1995-10-27

MINISCOPE MS-3

Applicant Schiller America, Inc.

K number K954066

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DPS 1995-10-24

HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER

Applicant Aerotel, Ltd.

K number K950004

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DPS 1995-10-19

6200 VITAL SIGNS MONITOR

Applicant Bci Intl., Inc.

K number K953415

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DPS 1995-08-11

HEWLETT-PACKARD MODEL M1264B CATHSTATION

Applicant Hewlett-Packard Co.

K number K952173

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DPS 1995-06-28

QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH

Applicant Quinton, Inc.

K number K945626

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DPS 1995-06-16

DINAMAP PLUS VITAL SIGNS MONOITOR

Applicant Critikon Company, LLC

K number K943709

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DPS 1995-04-25

HEART RATE VARIABILITY SOFTWARE OPTION

Applicant Spacelabs, Inc.

K number K950779

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DPS 1995-03-16

CARDIOVIT AT-1, P-80

Applicant Schiller America, Inc.

K number K946205

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DPS 1994-12-30

DATEX AS/3 PATIENT MONITOR

Applicant Datex Division Instrumentarium Corp.

K number K933156

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DPS 1994-10-20

MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION

Applicant Marquette Electronics, Inc.

K number K935394

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DPS 1994-08-18

NCE REPLACEMENT BATTERIES

Applicant National Custom Ent., Inc.

K number K942629

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DPS 1994-05-17

HP M1175A, M1176A, COMPONENT MONITORING SYSTEM

Applicant Hewlett-Packard Co.

K number K941811

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DPS 1994-02-17

RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR

Applicant Portable Power Systems, Inc.

K number K934439

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DPS 1994-02-17

BATTERY PACK# S1009LA

Applicant Portable Power Systems, Inc.

K number K933065

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DPS 1994-02-09

CRITIKON CENTRAL STATIN MONITOR

Applicant Critikon Company, LLC

K number K933404

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DPS 1993-09-22

BIOSCOPE

Applicant Biotronik, GmbH & Co.

K number K923406

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