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DQK

435 FDA 510(k) clearances · Product code

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RecordFirmDate
CARDIOSOFT/CASE CARDIAC TESTING SYSTEM (K031561)Ge Medical Systems Information Technologies2003-08-01
REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE (K031550)Vivometrics, Inc.2003-07-29
LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0 (K031000)C.R. Bard, Inc.2003-06-03
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 (K030129)Endocardial Solutions, Inc.2003-04-22
BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) (K022596)Clover Hi-Tech, Inc.2003-01-31
CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM (K020863)Biosense Webster, Inc.2003-01-09
CHEETAH I.V.D.S., MODEL 2002P (K023370)Cheetah Medical, Inc.2002-12-24
PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 (K023112)Problem Solving Concepts, Inc.2002-12-17
T-WAVE ALTERMANS (TWA) ALGORITHM OPTION (K023380)General Electric Medical Systems Information Techn2002-12-03
NEWCOR (K020440)Siemens Medical Systems, Inc.2002-12-03
RADIANALYZER, MODEL 12710 (K022188)Radi Medical Systems AB2002-10-03
QIVA (K021495)Pie Medical Imaging BV2002-10-01
CARDIS (K023015)Schwarzer GmbH2002-09-25
QUINTON Q-CATH, MODEL 000460 (K021906)Quinton, Inc.2002-09-04
MAC-LAB/CARDIOLAB EP/COMBOLAB (K021366)General Electric Medical Systems Information Techn2002-07-03
PHYSIOLOG, SERIES 95000 (K013032)Camtronics, Ltd.2002-06-04
LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE (K011903)Vivometrics, Inc.2002-04-12
ASTRONOMER PLUS SYSTEM (K013349)Ep Technologies, Inc.2002-04-09
HEARTTRENDS (K012825)Lev-El, Ltd.2002-03-19
SMARTFLOW PULSE TRANSMISSION COEFFICIENT (K020127)Florence Medical , Ltd.2002-02-14
CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM (K012089)Catheffects, LLC2002-01-28
MAC 5000 ECG ANALYSIS SYSTEM (K014108)General Electric Medical Systems Information Techn2002-01-10
CARTO XP EP NAVIGATION SYSTEM (K013083)Biosense Webster, Inc.2001-11-21
ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM (K012206)Cambridge Heart, Inc.2001-10-12
SMARTFLOW (K012947)Florence Medical , Ltd.2001-10-02
RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC (K012020)Non-Invasive Monitoring Systems, Inc.2001-08-21
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM (K011324)Cambridge Heart, Inc.2001-05-23
SYNETEC (K002817)Ela Medical, Inc.2001-05-02
CH 2000 CARDIAC DIAGNOSTIC SYSTEM (K010756)Cambridge Heart, Inc.2001-04-12
LOCALISA CARDIAC NAVIGATION SYSTEM (K002869)Medtronic Surgical Navigation Technologies2001-03-27
ASTRONOMER+WITH SLD (K003362)Boston Scientific Corp2001-03-01
PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE (K001852)Itamar Medical (C.M.) 1997 , Ltd.2001-02-21
ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS (K003492)Cambridge Heart, Inc.2001-01-18
CATHCOR DESKTOP (K002137)Siemens Elema AB2000-10-05
MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM (K002544)Oxford Instruments2000-09-13
RESPIEVENTS, VERSION 4.2 (K001369)Non-Invasive Monitoring Systems, Inc.2000-07-26
MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM (K001305)General Electric Medical Systems Information Techn2000-06-27
ECHOCOM, IMAGECOM, DOKUCOM (K001592)Tomtec Imaging Systems GmbH2000-06-16
ENSITE 3000 SYSTEM, MODEL EE3000 (K001437)Endocardial Solutions, Inc.2000-06-07
CARTO EP NAVIGATION SYSTEM (K000248)Biosense Webster, Inc.2000-05-05
MODIFICATION TO CARTO EP NAVIGATION SYSTEM (K000190)Biosense Webster, Inc.2000-05-05
NOGA CARDIAC NAVIGATION SYSTEM (K000332)Biosense Webster, Inc.2000-05-04
EP MEDSYSTEMS, EP-WORKMATE (K994011)Ep Medsystems, Inc.2000-03-23
CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800 (K992703)Premier Heart, LLC2000-03-21
QMS MAPPING SYSTEM,MODEL 2000 (K990058)Cathdata, Inc.1999-12-15
MODIFICATION TO CARTO EP NAVIGATION SYSTEM (K993729)Biosense Webster, Inc.1999-12-03
ENSITE 3000 SYSTEM (K992479)Endocardial Solutions, Inc.1999-12-02
MAC-LAB SYSTEM (K992948)General Electric Medical Systems Information Techn1999-11-29
SYNEFLASH & SYNEVIEW (K990727)Ela Medical, Inc.1999-11-26
IMPRESARIO (K993620)Del Mar Medical Systems, LLC1999-11-12
CARTO EP NAVIGATION SYSTEM (K992968)Biosense Webster, Inc.1999-09-29
MODIFICATION OF NOGA (K990494)Biosense, Inc.1999-09-03
BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 (K990956)Biosensor Corp.1999-06-14
CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000 (K983102)Cambridge Heart, Inc.1999-04-12
MT-200 (K973751)Schiller America, Inc.1998-08-25
BIOSENSOR HOLTER MONITOR SYSTEM (K974192)Biosensor Corp.1998-03-04
BIOSENSOR HOLTER MONITOR SYSTEM (K974546)Biosensor Corp.1998-03-04
NIVP3 (WINDOWS VERSION OF NIVP (K970570)D. E. Hokanson, Inc.1997-10-03
SPACELABS MEDICAL ECG ANALYSIS SYSTEM (K962930)Spacelabs Medical, Inc.1997-04-25
EIDOS 5003 HOLTER SYSTEM (K952969)New Product Development, Inc.1996-07-16
PATHFINDER 700 HOLTER ANALYZER (K951902)Reynolds Medical , Ltd.1996-07-15
AMBULATORY (HOLTER) RECORDING SYSTEM (K950944)Biosensor Corp.1996-06-18
STRESSWRITER EXERCISE TESTING SYSTEM (K961009)Hewlett-Packard Co.1996-06-17
AS/3 CARDIAC OUTPUT & SVO2 MODULE (K961063)Datex Medical Instrumentation, Inc.1996-05-31
ZYMED HOLTER SCANNER MODEL 2010 (K955015)Zymed Medical Instrumentation1996-03-18
ACCUSTRESS EXERCISE TESTING SYSTEM (K953127)Hewlett-Packard Co.1996-02-29
RESPITRACE PT (K942852)Non-Invasive Monitoring Systems, Inc.1996-02-13
RESPIEVENTS (K942771)Non-Invasive Monitoring Systems, Inc.1996-02-13
AMBULATORY (HOLTER) RECORDING SYSTEM (K950723)Biosensor Corp.1996-02-09
OMEGA CARES SYSTEM (K945068)J-F Medical Systems Intl., Inc.1996-01-25
HOLTER 6000 (K950988)Omega Medical Services, Inc.1996-01-04
CARTO SYSTEM (K954395)Biosense, Ltd.1995-12-21
EPICARDIA (K952846)Medicomp, Inc.1995-09-18
PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 (K945985)Burdick, Inc.1995-07-03
CMS SYSTEM (K922528)Micromedical Industries, Ltd.1995-05-12
EMI MODEL FFF-IA (K952164)New York Heart Instruments, Inc.1995-05-10
HOLTER FOR WINDOWS (K930564)North East Monitoring, Inc.1995-04-19
SIEMENS CLINICAL WORK STATION (K935043)Siemens Medical Electronics1995-04-07
INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS) (K941762)Hogan & Hartson1995-02-22
ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY (K935186)Electrophysiology Systems, Inc.1995-01-03
ALTAIR-DISC RECORDER (K942565)Burdick Corp.1994-12-05
ZYMED HOLTER SCANNER MODEL 2010 (K930806)Agilent Technologies1994-04-25
COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT. (K931900)Archival Technologies, Inc.1994-03-11
AVOXIMETER (K932954)A-Vox Systems, Inc.1993-12-27
ON-LINE ANALYSIS SYSTEM (K930639)Softheart, Inc.1993-09-22
DUALTHERM(R) CARDIAC OUTPUT COMPUTER (K925285)B. Braun of America, Inc.1993-07-21
PHYSIOLOGICAL MEASUREMENT AND DISPLAY SYSTEMS (K920587)Siemens Medical Solutions USA, Inc.1993-01-15
CENTRA II ANALYSIS SYSTEM (K922171)Marquette Electronics, Inc.1992-12-28
OFF-LINE ANALYSIS SYSTEM (K921216)Softheart, Inc.1992-11-20
MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED) (K920295)Oxford Medilog, Inc.1992-08-18
RHYTHMSCAN PRECISION 6000 (K914577)Precision Health Care Systems, Inc.1992-05-08
ALTAIR (K912728)Diagnostic Medical Instruments1992-02-27
CATHWRITER(TM) (K914105)Softheart, Inc.1992-02-26
HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 (K911615)Diagnostic Monitoring Software1992-01-08
MODEL 100 CENTRAL STATION (K913193)Protocol Systems, Inc.1991-10-16
NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS (K905248)Advanced Technology Laboratories, Inc.1991-02-28
HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST (K905100)Hewlett-Packard Co.1991-01-15
CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS (K900814)Intellimetrics Instrument Corp.1990-12-17
THE OPHTHIMUS SYSTEM (K896017)Hightech Vision1990-10-02
PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) (K902716)Prucka Engineering, Inc.1990-09-04
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