FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K932954 |
A-VOX SYSTEMS, INC. |
AVOXIMETER |
12/27/1993 |
K183128 |
Abbott |
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 |
12/12/2018 |
K182644 |
Abbott |
EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 |
10/19/2018 |
K161240 |
Abbott Electrophysiology |
Rhythm View Workstation (non-streaming) |
08/10/2016 |
K171583 |
Abbott Electrophysiology |
RhythmView Workstation |
09/01/2017 |
K201148 |
Abbott Medical |
EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License |
06/26/2020 |
K201181 |
Abbott Medical |
EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System |
06/26/2020 |
K193013 |
Acutus Medical, Inc. |
AcQMap High Resolution Imaging and Mapping System |
02/11/2020 |
K170948 |
Acutus Medical, Inc. |
AcQMap High Resolution Imaging and Mapping System |
10/16/2017 |
K181577 |
Acutus Medical, Inc. |
AcQMap High Resolution Imaging and Mapping System |
02/07/2019 |
K190131 |
Acutus Medical, Inc. |
AcQMap High Resolution Imaging and Mapping System |
04/02/2019 |
K191392 |
Acutus Medical, Inc. |
AcQMap High Resolution Imaging and Mapping System |
09/06/2019 |
K143449 |
ADAMS MEDITECH LLC |
ADH 200 Analyzer Software |
06/26/2015 |
K905248 |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS |
02/28/1991 |
K930806 |
AGILENT TECHNOLOGIES |
ZYMED HOLTER SCANNER MODEL 2010 |
04/25/1994 |
K181823 |
AliveCor, Inc. |
KardiaAI |
03/11/2019 |
K152160 |
APN Health, LLC |
Navik 3D |
02/23/2016 |
K931900 |
ARCHIVAL TECHNOLOGIES, INC. |
COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT. |
03/11/1994 |
K925285 |
B. BRAUN OF AMERICA, INC. |
DUALTHERM(R) CARDIAC OUTPUT COMPUTER |
07/21/1993 |
K780530 |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
AUTOMATED PHYSIOLOGIC PROFILER |
04/28/1978 |
K182344 |
Biofourmis Singapore Pte. Ltd. |
RhythmAnalytics |
03/07/2019 |
K090017 |
BIOSENSE WEBSTER, INC. |
CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES |
10/13/2009 |
K103746 |
BIOSENSE WEBSTER, INC. |
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) |
01/21/2011 |
K112007 |
BIOSENSE WEBSTER, INC. |
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 |
10/05/2011 |
K133916 |
BIOSENSE WEBSTER, INC. |
CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 |
07/01/2014 |
K173977 |
Biosense Webster, Inc. |
CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module |
06/14/2018 |
K173978 |
Biosense Webster, Inc. |
CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module |
08/24/2018 |
K170600 |
Biosense Webster, Inc. |
CARTO 3 EP Navigation System, Version 6.0 and Accessories |
07/25/2017 |
K180238 |
Biosense Webster, Inc. |
CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT |
06/01/2018 |
K191660 |
Biosense Webster, Inc. |
CARTO 3 EP Navigation System, Version 7.1 and Accessories |
07/20/2019 |
K072202 |
BIOSENSE WEBSTER, INC. |
CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) |
11/19/2007 |
K093455 |
BIOSENSE WEBSTER, INC. |
CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES |
12/04/2009 |
K992968 |
BIOSENSE WEBSTER, INC. |
CARTO EP NAVIGATION SYSTEM |
09/29/1999 |
K000248 |
BIOSENSE WEBSTER, INC. |
CARTO EP NAVIGATION SYSTEM |
05/05/2000 |
K042681 |
BIOSENSE WEBSTER, INC. |
CARTO RMT EP NAVIGATION SYSTEM |
09/29/2005 |
K091789 |
BIOSENSE WEBSTER, INC. |
CARTO RMT EP NAVIGATION SYSTEM V8 |
10/01/2009 |
K020863 |
BIOSENSE WEBSTER, INC. |
CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM |
01/09/2003 |
K013083 |
BIOSENSE WEBSTER, INC. |
CARTO XP EP NAVIGATION SYSTEM |
11/21/2001 |
K042999 |
BIOSENSE WEBSTER, INC. |
CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8 |
03/21/2005 |
K093566 |
BIOSENSE WEBSTER, INC. |
CARTO XP EP NAVIGATION SYSTEM, VERSION 10 |
06/18/2010 |
K070240 |
BIOSENSE WEBSTER, INC. |
CARTO XP EP NAVIGATION SYSTEM, VERSION 9 |
05/04/2007 |
K120550 |
BIOSENSE WEBSTER, INC. |
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) |
05/07/2012 |
K132782 |
BIOSENSE WEBSTER, INC. |
CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 |
01/24/2014 |
K993729 |
BIOSENSE WEBSTER, INC. |
MODIFICATION TO CARTO EP NAVIGATION SYSTEM |
12/03/1999 |
K000190 |
BIOSENSE WEBSTER, INC. |
MODIFICATION TO CARTO EP NAVIGATION SYSTEM |
05/05/2000 |
K000332 |
BIOSENSE WEBSTER, INC. |
NOGA CARDIAC NAVIGATION SYSTEM |
05/04/2000 |
K053194 |
BIOSENSE WEBSTER, INC. |
NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE |
03/09/2006 |
K990494 |
BIOSENSE, INC. |
MODIFICATION OF NOGA |
09/03/1999 |
K954395 |
BIOSENSE, LTD. |
CARTO SYSTEM |
12/21/1995 |
K950723 |
BIOSENSOR CORP. |
AMBULATORY (HOLTER) RECORDING SYSTEM |
02/09/1996 |
K950944 |
BIOSENSOR CORP. |
AMBULATORY (HOLTER) RECORDING SYSTEM |
06/18/1996 |
K974192 |
BIOSENSOR CORP. |
BIOSENSOR HOLTER MONITOR SYSTEM |
03/04/1998 |
K974546 |
BIOSENSOR CORP. |
BIOSENSOR HOLTER MONITOR SYSTEM |
03/04/1998 |
K990956 |
BIOSENSOR CORP. |
BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 |
06/14/1999 |
K180805 |
BioSig Technologies |
Pure EP |
08/08/2018 |
K201178 |
Boston Scientific |
iLab Polaris Multi-Modality Guidance System |
05/29/2020 |
K003362 |
BOSTON SCIENTIFIC CORP. |
ASTRONOMER+WITH SLD |
03/01/2001 |
K141185 |
BOSTON SCIENTIFIC CORP. |
V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM |
06/06/2014 |
K201713 |
Boston Scientific Corporation |
AVVIGO Guidance System |
07/23/2020 |
K191008 |
Boston Scientific Corporation |
iLab Polaris Multi-Modality Guidance System |
07/02/2019 |
K151613 |
BOSTON SCIENTIFIC CORPORATION |
iLab Polaris Multi-Modality Guidance System |
10/06/2015 |
K162793 |
Boston Scientific Corporation |
RHYTHMIA HDx Mapping System |
03/10/2017 |
K173837 |
Boston Scientific Corporation |
RHYTHMIA HDx Mapping System (with software Version 2.0) |
07/25/2018 |
K192438 |
Boston Scientific Corporation |
Rhythmia HDxTM Mapping System |
11/27/2019 |
K942565 |
BURDICK CORP. |
ALTAIR-DISC RECORDER |
12/05/1994 |
K945985 |
BURDICK, INC. |
PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 |
07/03/1995 |
K101331 |
C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION |
LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE |
10/08/2010 |
K113811 |
C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION |
V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM |
03/16/2012 |
K031000 |
C.R. BARD, INC. |
LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0 |
06/03/2003 |
K012206 |
CAMBRIDGE HEART, INC. |
ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM |
10/12/2001 |
K003492 |
CAMBRIDGE HEART, INC. |
ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS |
01/18/2001 |
K011324 |
CAMBRIDGE HEART, INC. |
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM |
05/23/2001 |
K100362 |
CAMBRIDGE HEART, INC. |
CAMBRIDGE HEART OEM |
04/14/2010 |
K983102 |
CAMBRIDGE HEART, INC. |
CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000 |
04/12/1999 |
K010756 |
CAMBRIDGE HEART, INC. |
CH 2000 CARDIAC DIAGNOSTIC SYSTEM |
04/12/2001 |
K050225 |
CAMBRIDGE HEART, INC. |
HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM |
04/07/2005 |
K013032 |
CAMTRONICS, LTD. |
PHYSIOLOG, SERIES 95000 |
06/04/2002 |
K131045 |
CARDIAC DESIGNS, LLC |
ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE |
05/29/2013 |
K161245 |
CARDIO TEK, BV |
EP-TRACER System |
08/05/2016 |
K042849 |
CARDIOBIOMEDICAL CORPORATION |
CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD) |
01/13/2005 |
K162440 |
CARDIOINSIGHT TECHNOLOGIES, INC |
CardioInsight Cardiac Mapping System |
11/04/2016 |
K140497 |
CARDIOINSIGHT TECHNOLOGIES, INC |
ECVUE MAPPING SYSTEM |
11/19/2014 |
K150990 |
CardioInsight Technologies, Inc. |
ECVUE Mapping System |
07/02/2015 |
K134044 |
CARDIOTEK, B.V. |
EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM |
03/31/2014 |
K153654 |
CareFusion Germany 234 GmbH |
Sentry WEB SmartInterp |
09/16/2016 |
K990058 |
CATHDATA, INC. |
QMS MAPPING SYSTEM,MODEL 2000 |
12/15/1999 |
K012089 |
CATHEFFECTS, LLC. |
CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM |
01/28/2002 |
K183195 |
Catheter Precision, Inc. |
VIVO |
06/14/2019 |
K200313 |
Catheter Precision, Inc. |
VIVO |
09/14/2020 |
K190106 |
Centerline Biomedical, Inc. |
Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle |
06/24/2019 |
K023370 |
CHEETAH MEDICAL INC. |
CHEETAH I.V.D.S., MODEL 2002P |
12/24/2002 |
K840875 |
CLINICAL MICROSYSTEMS INTL. |
MULTIVARIATE DIGITAL CARDIOGRAPH |
07/06/1984 |
K022596 |
CLOVER HI-TECH INC. |
BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) |
01/31/2003 |
K883152 |
COHERENT SYSTEMS, INC. |
EP-STAT |
10/13/1988 |
K871436 |
CORAZONIX CORP. |
PREDICTOR |
06/19/1987 |
K865035 |
CRITICAL CARE SYSTEMS, INC. |
RECORD KEEPING/DATA MANAGEMENT SYSTEM |
05/11/1987 |
K860854 |
CYGNUS OF SOUTH FLORIDA, INC. |
CRITICALC |
12/08/1986 |
K970570 |
D. E. HOKANSON, INC. |
NIVP3 (WINDOWS VERSION OF NIVP |
10/03/1997 |
K072752 |
DATADANCER MEDICAL SYSTEMS |
BP LIMBO XL, BPTANGO XL, BP SALSA XL |
10/31/2008 |
K961063 |
DATEX MEDICAL INSTRUMENTATION, INC. |
AS/3 CARDIAC OUTPUT & SVO2 MODULE |
05/31/1996 |
K052883 |
DATRIX |
CARDIOSERVER |
11/01/2005 |
K993620 |
DEL MAR MEDICAL SYSTEMS, LLC. |
IMPRESARIO |
11/12/1999 |
K912728 |
DIAGNOSTIC MEDICAL INSTRUMENTS |
ALTAIR |
02/27/1992 |
K911615 |
DIAGNOSTIC MONITORING SOFTWARE |
HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 |
01/08/1992 |
K800766 |
DIGISONICS, INC. |
ECHO-COMP |
04/24/1980 |
K151787 |
EDAN INSTRUMENTS, INC. |
Holter System |
01/27/2016 |
K191089 |
Edwards LifeSciences, LLC |
Edwards Pressure Cable |
06/13/2019 |
K180881 |
Edwards Lifesciences, LLC |
HemoSphere Advanced Monitor, HemoSphere Pressure Cable |
11/16/2018 |
K163381 |
Edwards Lifesciences, LLC |
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable |
04/14/2017 |
K190205 |
Edwards Lifesciences, LLC |
HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module |
08/29/2019 |
K042002 |
ELA MEDICAL INC |
SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER |
10/20/2004 |
K990727 |
ELA MEDICAL, INC. |
SYNEFLASH & SYNEVIEW |
11/26/1999 |
K002817 |
ELA MEDICAL, INC. |
SYNETEC |
05/02/2001 |
K935186 |
ELECTROPHYSIOLOGY SYSTEMS, INC. |
ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY |
01/03/1995 |
K082421 |
EMAGEON INC. |
HEARTSUITE HEMODYNAMICS 7.10 |
12/17/2008 |
K992479 |
ENDOCARDIAL SOLUTIONS, INC. |
ENSITE 3000 SYSTEM |
12/02/1999 |
K001437 |
ENDOCARDIAL SOLUTIONS, INC. |
ENSITE 3000 SYSTEM, MODEL EE3000 |
06/07/2000 |
K033211 |
ENDOCARDIAL SOLUTIONS, INC. |
ENSITE SYSTEM |
10/30/2003 |
K042493 |
ENDOCARDIAL SOLUTIONS, INC. |
ENSITE SYSTEM, MODEL EE3000 |
10/15/2004 |
K030129 |
ENDOCARDIAL SOLUTIONS, INC. |
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 |
04/22/2003 |
K060980 |
ENDOTHELIX, INC. |
VENDYS MODEL 5000 B/BC |
08/16/2007 |
K072919 |
ENDOTHELIX, INC. |
VENDYS, MODEL 6000 B B/C |
11/02/2007 |
K063113 |
EP MEDSYSTEMS |
EP-WORKMATE |
10/27/2006 |
K070706 |
EP MEDSYSTEMS |
EP-WORKMATE |
04/11/2007 |
K032225 |
EP MEDSYSTEMS |
EP-WORKMATE WITH RPM SYSTEM |
08/20/2003 |
K994011 |
EP MEDSYSTEMS, INC. |
EP MEDSYSTEMS, EP-WORKMATE |
03/23/2000 |
K063277 |
EP MEDSYSTEMS, INC. |
MAPMATE |
11/30/2006 |
K013349 |
EP TECHNOLOGIES, INC. |
ASTRONOMER PLUS SYSTEM |
04/09/2002 |
K181720 |
Epiphany Healthcare, LLC |
Epiphany Cardio Server Mobile |
07/30/2018 |
K872928 |
FIDELITY MEDICAL, INC. |
LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH |
01/06/1988 |
K012947 |
FLORENCE MEDICAL LTD. |
SMARTFLOW |
10/02/2001 |
K020127 |
FLORENCE MEDICAL LTD. |
SMARTFLOW PULSE TRANSMISSION COEFFICIENT |
02/14/2002 |
K030145 |
GALIX BIOMEDICAL INSTRUMENTATION, INC. |
GALIX WINTER |
09/17/2003 |
K052977 |
GE HEALTHCARE |
DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES |
11/22/2005 |
K052976 |
GE HEALTHCARE |
DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES |
01/13/2006 |
K111200 |
GE HEALTHCARE |
MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM |
10/12/2011 |
K061741 |
GE HEALTHCARE |
MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM |
09/15/2006 |
K042148 |
GE MEDICAL SYST. INFORMATION TECHNOLOGIES |
HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES |
12/03/2004 |
K031561 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
CARDIOSOFT/CASE CARDIAC TESTING SYSTEM |
08/01/2003 |
K050093 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM |
05/13/2005 |
K051026 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MARS HOLTER ANALYSIS WORKSTATION |
07/19/2005 |
K093141 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MARS HOLTER ANALYSIS WORKSTATION |
12/29/2009 |
K032577 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM |
10/10/2003 |
K072502 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM |
11/19/2007 |
K050614 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MUSE CARDIOLOGY INFORMATION SYSTEM |
04/05/2005 |
K083639 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE |
02/17/2009 |
K032513 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
T-WAVE ALTERNANS (TWA) ALGORITHM OPTION |
10/30/2003 |
K103678 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH |
CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM |
02/16/2011 |
K130626 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS |
05/01/2013 |
K132437 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
MARS HOLTER ANALYSIS WORKSTATION |
12/04/2013 |
K152993 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
MUSE Cardiology Information System |
01/12/2016 |
K110132 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
MUSE CARDIOLOGY INFORMATION SYSTEM |
05/25/2011 |
K130155 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
MUSE CARDIOLOGY INFORMATION SYSTEM |
03/01/2013 |
K810750 |
GENERAL ELECTRIC CO. |
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE |
03/27/1981 |
K014108 |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
MAC 5000 ECG ANALYSIS SYSTEM |
01/10/2002 |
K992948 |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
MAC-LAB SYSTEM |
11/29/1999 |
K001305 |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM |
06/27/2000 |
K021366 |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
MAC-LAB/CARDIOLAB EP/COMBOLAB |
07/03/2002 |
K023380 |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
T-WAVE ALTERMANS (TWA) ALGORITHM OPTION |
12/03/2002 |
K051471 |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
CARDIODAY |
06/29/2005 |
K130516 |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
CARDIODAY |
08/23/2013 |
K162023 |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
CardioDay V2.5 |
03/24/2017 |
K070280 |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
CARDIODAY, VERSION 2.0 |
02/23/2007 |
K810731 |
GOULD, INC. |
MODEL IM1000 INTEGRATED MONITOR |
03/27/1981 |
K953127 |
HEWLETT-PACKARD CO. |
ACCUSTRESS EXERCISE TESTING SYSTEM |
02/29/1996 |
K905100 |
HEWLETT-PACKARD CO. |
HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST |
01/15/1991 |
K780768 |
HEWLETT-PACKARD CO. |
MODEL 5621A INTERFACE |
05/26/1978 |
K874171 |
HEWLETT-PACKARD CO. |
MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM |
02/05/1988 |
K961009 |
HEWLETT-PACKARD CO. |
STRESSWRITER EXERCISE TESTING SYSTEM |
06/17/1996 |
K896017 |
HIGHTECH VISION |
THE OPHTHIMUS SYSTEM |
10/02/1990 |
K941762 |
HOGAN & HARTSON |
INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS) |
02/22/1995 |
K792677 |
HONEYWELL, INC. |
DATABASE MANAGEMENT & REPORTING SYSTEM |
01/04/1980 |
K760767 |
HONEYWELL, INC. |
MEDDARS CARDIOVASCULAR DIAGNOSTIC SYSTEM |
10/13/1976 |
K053369 |
HUNTLEIGH HEALTHCARE |
MEDILOG DARWIN HOLTER ANALYSIS |
12/22/2005 |
K071911 |
INNOVISION A/S |
CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR |
09/07/2007 |
K051907 |
INNOVISION A/S |
INNOCOR |
03/02/2006 |
K770705 |
INSTRUMENTS FOR CARDIAC RESEARCH |
CARDIAC ACQUISITION SYSTEM, ICR 2001 |
06/02/1977 |
K900814 |
INTELLIMETRICS INSTRUMENT CORP. |
CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS |
12/17/1990 |
K842339 |
INTL. MEDICAL, INC. |
COMPUSTRESS STRESS TESTING SYS |
12/19/1984 |
K792525 |
IREX CORP. |
IREX CARDIOPLAN |
12/27/1979 |
K091075 |
IRHYTHM TECHNOLOGIES, INC. |
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM |
07/21/2009 |
K142681 |
iRhythm Technologies, Inc. |
ZEUS (ZIO ECG Utilization Service) System |
11/21/2014 |
K181502 |
iRhythm Technologies, Inc. |
Zio AT ECG Monitoring System, ZEUS System |
08/29/2018 |
K190593 |
iRhythm Technologies, Inc. |
Zio XT ECG Monitoring System, Zio AT ECG Monitoring System |
08/23/2019 |
K032519 |
ITAMAR MEDICAL |
ENDO PAT 2000 |
11/12/2003 |
K001852 |
ITAMAR MEDICAL (C.M.) 1997 LTD. |
PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE |
02/21/2001 |
K945068 |
J-F MEDICAL SYSTEMS INTL., INC. |
OMEGA CARES SYSTEM |
01/25/1996 |
K812354 |
KONTRON INSTRUMENTS, INC. |
KONTRON PMS 7000 |
09/25/1981 |
K800092 |
KT MEDICAL, INC. |
COMBISON COMPUTER |
04/08/1980 |
K012825 |
LEV-EL, LTD. |
HEARTTRENDS |
03/19/2002 |
K123466 |
LUMEDX |
HEALTHVIEW ECG MANAGER |
12/20/2012 |
K922171 |
MARQUETTE ELECTRONICS, INC. |
CENTRA II ANALYSIS SYSTEM |
12/28/1992 |
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