Computer, Diagnostic, Programmable

FDA product code DQK · 422 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1425
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-10-13 – 2026-09-17

DQK 2002-09-04

QUINTON Q-CATH, MODEL 000460

Applicant Quinton, Inc.

K number K021906

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DQK 2002-07-03

MAC-LAB/CARDIOLAB EP/COMBOLAB

Applicant General Electric Medical Systems Information Techn

K number K021366

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DQK 2002-06-04

PHYSIOLOG, SERIES 95000

Applicant Camtronics, Ltd.

K number K013032

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DQK 2002-04-12

LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE

Applicant Vivometrics, Inc.

K number K011903

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DQK 2002-04-09

ASTRONOMER PLUS SYSTEM

Applicant Ep Technologies, Inc.

K number K013349

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DQK 2002-03-19

HEARTTRENDS

Applicant Lev-El, Ltd.

K number K012825

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DQK 2002-02-14

SMARTFLOW PULSE TRANSMISSION COEFFICIENT

Applicant Florence Medical , Ltd.

K number K020127

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DQK 2002-01-28

CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM

Applicant Catheffects, LLC

K number K012089

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DQK 2002-01-10

MAC 5000 ECG ANALYSIS SYSTEM

Applicant General Electric Medical Systems Information Techn

K number K014108

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DQK 2001-11-21

CARTO XP EP NAVIGATION SYSTEM

Applicant Biosense Webster, Inc.

K number K013083

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DQK 2001-10-12

ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM

Applicant Cambridge Heart, Inc.

K number K012206

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DQK 2001-10-02

SMARTFLOW

Applicant Florence Medical , Ltd.

K number K012947

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DQK 2001-08-21

RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC

Applicant Non-Invasive Monitoring Systems, Inc.

K number K012020

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DQK 2001-05-23

CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM

Applicant Cambridge Heart, Inc.

K number K011324

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DQK 2001-05-02

SYNETEC

Applicant Ela Medical, Inc.

K number K002817

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DQK 2001-04-12

CH 2000 CARDIAC DIAGNOSTIC SYSTEM

Applicant Cambridge Heart, Inc.

K number K010756

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DQK 2001-03-27

LOCALISA CARDIAC NAVIGATION SYSTEM

Applicant Medtronic Surgical Navigation Technologies

K number K002869

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DQK 2001-03-01

ASTRONOMER+WITH SLD

Applicant Boston Scientific Corp

K number K003362

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DQK 2001-02-21

PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE

Applicant Itamar Medical (C.M.) 1997 , Ltd.

K number K001852

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DQK 2001-01-18

ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS

Applicant Cambridge Heart, Inc.

K number K003492

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DQK 2000-10-05

CATHCOR DESKTOP

Applicant Siemens Elema AB

K number K002137

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DQK 2000-09-13

MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM

Applicant Oxford Instruments

K number K002544

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DQK 2000-07-26

RESPIEVENTS, VERSION 4.2

Applicant Non-Invasive Monitoring Systems, Inc.

K number K001369

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DQK 2000-06-27

MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM

Applicant General Electric Medical Systems Information Techn

K number K001305

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DQK 2000-06-16

ECHOCOM, IMAGECOM, DOKUCOM

Applicant Tomtec Imaging Systems GmbH

K number K001592

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DQK 2000-06-07

ENSITE 3000 SYSTEM, MODEL EE3000

Applicant Endocardial Solutions, Inc.

K number K001437

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DQK 2000-05-05

CARTO EP NAVIGATION SYSTEM

Applicant Biosense Webster, Inc.

K number K000248

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DQK 2000-05-05

MODIFICATION TO CARTO EP NAVIGATION SYSTEM

Applicant Biosense Webster, Inc.

K number K000190

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DQK 2000-05-04

NOGA CARDIAC NAVIGATION SYSTEM

Applicant Biosense Webster, Inc.

K number K000332

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DQK 2000-03-23

EP MEDSYSTEMS, EP-WORKMATE

Applicant Ep Medsystems, Inc.

K number K994011

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DQK 2000-03-21

CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800

Applicant Premier Heart, LLC

K number K992703

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DQK 1999-12-15

QMS MAPPING SYSTEM,MODEL 2000

Applicant Cathdata, Inc.

K number K990058

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DQK 1999-12-03

MODIFICATION TO CARTO EP NAVIGATION SYSTEM

Applicant Biosense Webster, Inc.

K number K993729

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DQK 1999-12-02

ENSITE 3000 SYSTEM

Applicant Endocardial Solutions, Inc.

K number K992479

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DQK 1999-11-29

MAC-LAB SYSTEM

Applicant General Electric Medical Systems Information Techn

K number K992948

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DQK 1999-11-26

SYNEFLASH & SYNEVIEW

Applicant Ela Medical, Inc.

K number K990727

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DQK 1999-11-12

IMPRESARIO

Applicant Del Mar Medical Systems, LLC

K number K993620

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DQK 1999-09-29

CARTO EP NAVIGATION SYSTEM

Applicant Biosense Webster, Inc.

K number K992968

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DQK 1999-09-03

MODIFICATION OF NOGA

Applicant Biosense, Inc.

K number K990494

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DQK 1999-06-14

BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005

Applicant Biosensor Corp.

K number K990956

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DQK 1999-04-12

CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000

Applicant Cambridge Heart, Inc.

K number K983102

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DQK 1998-08-25

MT-200

Applicant Schiller America, Inc.

K number K973751

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DQK 1998-03-04

BIOSENSOR HOLTER MONITOR SYSTEM

Applicant Biosensor Corp.

K number K974546

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DQK 1998-03-04

BIOSENSOR HOLTER MONITOR SYSTEM

Applicant Biosensor Corp.

K number K974192

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DQK 1997-10-03

NIVP3 (WINDOWS VERSION OF NIVP

Applicant D. E. Hokanson, Inc.

K number K970570

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DQK 1997-04-25

SPACELABS MEDICAL ECG ANALYSIS SYSTEM

Applicant Spacelabs Medical, Inc.

K number K962930

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DQK 1996-07-16

EIDOS 5003 HOLTER SYSTEM

Applicant New Product Development, Inc.

K number K952969

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DQK 1996-07-15

PATHFINDER 700 HOLTER ANALYZER

Applicant Reynolds Medical , Ltd.

K number K951902

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DQK 1996-06-18

AMBULATORY (HOLTER) RECORDING SYSTEM

Applicant Biosensor Corp.

K number K950944

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DQK 1996-06-17

STRESSWRITER EXERCISE TESTING SYSTEM

Applicant Hewlett-Packard Co.

K number K961009

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DQK 1996-05-31

AS/3 CARDIAC OUTPUT & SVO2 MODULE

Applicant Datex Medical Instrumentation, Inc.

K number K961063

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DQK 1996-03-18

ZYMED HOLTER SCANNER MODEL 2010

Applicant Zymed Medical Instrumentation

K number K955015

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DQK 1996-02-29

ACCUSTRESS EXERCISE TESTING SYSTEM

Applicant Hewlett-Packard Co.

K number K953127

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DQK 1996-02-13

RESPITRACE PT

Applicant Non-Invasive Monitoring Systems, Inc.

K number K942852

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DQK 1996-02-13

RESPIEVENTS

Applicant Non-Invasive Monitoring Systems, Inc.

K number K942771

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DQK 1996-02-09

AMBULATORY (HOLTER) RECORDING SYSTEM

Applicant Biosensor Corp.

K number K950723

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DQK 1996-01-25

OMEGA CARES SYSTEM

Applicant J-F Medical Systems Intl., Inc.

K number K945068

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DQK 1996-01-04

HOLTER 6000

Applicant Omega Medical Services, Inc.

K number K950988

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DQK 1995-12-21

CARTO SYSTEM

Applicant Biosense, Ltd.

K number K954395

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DQK 1995-09-18

EPICARDIA

Applicant Medicomp, Inc.

K number K952846

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DQK 1995-07-03

PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400

Applicant Burdick, Inc.

K number K945985

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DQK 1995-05-12

CMS SYSTEM

Applicant Micromedical Industries, Ltd.

K number K922528

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DQK 1995-05-10

EMI MODEL FFF-IA

Applicant New York Heart Instruments, Inc.

K number K952164

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DQK 1995-04-19

HOLTER FOR WINDOWS

Applicant North East Monitoring, Inc.

K number K930564

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DQK 1995-04-07

SIEMENS CLINICAL WORK STATION

Applicant Siemens Medical Electronics

K number K935043

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DQK 1995-02-22

INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)

Applicant Hogan & Hartson

K number K941762

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DQK 1995-01-03

ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY

Applicant Electrophysiology Systems, Inc.

K number K935186

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DQK 1994-12-05

ALTAIR-DISC RECORDER

Applicant Burdick Corp.

K number K942565

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DQK 1994-04-25

ZYMED HOLTER SCANNER MODEL 2010

Applicant Agilent Technologies

K number K930806

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DQK 1994-03-11

COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT.

Applicant Archival Technologies, Inc.

K number K931900

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DQK 1993-12-27

AVOXIMETER

Applicant A-Vox Systems, Inc.

K number K932954

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DQK 1993-09-22

ON-LINE ANALYSIS SYSTEM

Applicant Softheart, Inc.

K number K930639

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DQK 1993-07-21

DUALTHERM(R) CARDIAC OUTPUT COMPUTER

Applicant B. Braun of America, Inc.

K number K925285

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DQK 1993-01-15

PHYSIOLOGICAL MEASUREMENT AND DISPLAY SYSTEMS

Applicant Siemens Medical Solutions USA, Inc.

K number K920587

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DQK 1992-12-28

CENTRA II ANALYSIS SYSTEM

Applicant Marquette Electronics, Inc.

K number K922171

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DQK 1992-11-20

OFF-LINE ANALYSIS SYSTEM

Applicant Softheart, Inc.

K number K921216

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DQK 1992-08-18

MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED)

Applicant Oxford Medilog, Inc.

K number K920295

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DQK 1992-05-08

RHYTHMSCAN PRECISION 6000

Applicant Precision Health Care Systems, Inc.

K number K914577

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DQK 1992-02-27

ALTAIR

Applicant Diagnostic Medical Instruments

K number K912728

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DQK 1992-02-26

CATHWRITER(TM)

Applicant Softheart, Inc.

K number K914105

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DQK 1992-01-08

HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300

Applicant Diagnostic Monitoring Software

K number K911615

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DQK 1991-10-16

MODEL 100 CENTRAL STATION

Applicant Protocol Systems, Inc.

K number K913193

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DQK 1991-02-28

NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS

Applicant Advanced Technology Laboratories, Inc.

K number K905248

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DQK 1991-01-15

HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST

Applicant Hewlett-Packard Co.

K number K905100

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DQK 1990-12-17

CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS

Applicant Intellimetrics Instrument Corp.

K number K900814

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DQK 1990-10-02

THE OPHTHIMUS SYSTEM

Applicant Hightech Vision

K number K896017

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DQK 1990-09-04

PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)

Applicant Prucka Engineering, Inc.

K number K902716

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DQK 1989-05-18

Q5000 PC WORKSTATION

Applicant Quinton, Inc.

K number K892113

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DQK 1988-10-13

EP-STAT

Applicant Coherent Systems, Inc.

K number K883152

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DQK 1988-06-02

WORKSTATION PLUS W/LOCAL AREA NETWORK(LAN) OPTION

Applicant Ppg Industries, Inc.

K number K880879

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DQK 1988-05-31

EPICARDIA LE/FD

Applicant Medicomp, Inc.

K number K881770

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DQK 1988-02-05

MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM

Applicant Hewlett-Packard Co.

K number K874171

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DQK 1988-01-06

LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH

Applicant Fidelity Medical, Inc.

K number K872928

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DQK 1987-07-06

MICOR

Applicant Siemens Medical Solutions USA, Inc.

K number K865010

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DQK 1987-06-19

PREDICTOR

Applicant Corazonix Corp.

K number K871436

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DQK 1987-05-11

RECORD KEEPING/DATA MANAGEMENT SYSTEM

Applicant Critical Care Systems, Inc.

K number K865035

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DQK 1987-05-11

CARDIAC PERFORMANCE MONITOR

Applicant Vascular Technology Incorporated

K number K864583

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DQK 1986-12-08

CRITICALC

Applicant Cygnus of South Florida, Inc.

K number K860854

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DQK 1986-10-31

QUINTON Q.CATH

Applicant Quinton, Inc.

K number K862740

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DQK 1986-02-12

PDS 9000 PATIENT DATA MGMT. SYSTEM

Applicant Marquette Electronics, Inc.

K number K855055

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