FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K010791 |
ADSIS LTD. |
REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) |
06/08/2001 |
K132206 |
ADVANCED FLUIDICS, LLC |
MELYS ATRIAL FIBRILLATION SCREENING MONITOR |
03/19/2014 |
K051544 |
ADVANCED MONITORING CAREGIVING INC. |
VITALCAREGIVING SYSTEM |
10/07/2005 |
K000775 |
AEROTEL MEDICAL SYSTEMS (1998) LTD. |
HEART 2005 |
05/17/2000 |
K032736 |
AEROTEL MEDICAL SYSTEMS (1998) LTD. |
HEART 2006 |
10/03/2003 |
K022073 |
AEROTEL MEDICAL SYSTEMS (1998) LTD. |
HEARTLINE RECEIVING STATION |
07/24/2002 |
K023418 |
AEROTEL MEDICAL SYSTEMS (1998) LTD. |
HEARTONE EVENT RECORDER AND TRANSMITTER |
11/06/2002 |
K961362 |
AEROTEL, LTD. |
AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE |
07/10/1996 |
K953762 |
AEROTEL, LTD. |
HEART 400 ECG TRANSMITTER |
07/18/1996 |
K980144 |
AEROTEL, LTD. |
HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER |
06/16/1998 |
K983626 |
ALARIS MEDICAL SYSTEMS, INC. |
KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II |
02/05/1999 |
K171816 |
AliveCor, Inc |
Kardia Band System |
11/16/2017 |
K140933 |
ALIVECOR, INC. |
ALIVECOR HEART MONITOR |
08/15/2014 |
K142672 |
ALIVECOR, INC. |
AliveCor Heart Monitor |
12/03/2014 |
K142743 |
AliveCor, Inc. |
AliveCor Heart Monitor |
01/27/2015 |
K220350 |
AliveCor, Inc. |
KardiaMobile 6L |
05/25/2022 |
K210753 |
AliveCor, Inc. |
KardiaMobile 6L |
06/30/2021 |
K211668 |
AliveCor, Inc. |
KardiaMobile Card |
11/30/2021 |
K182396 |
AliveCor, Inc. |
KardiaMobile, KardiaStation |
04/12/2019 |
K191406 |
AliveCor, Inc. |
KardiaMobile, KardiaStation |
01/24/2020 |
K183319 |
AliveCor, Inc. |
Triangle System |
05/10/2019 |
K173248 |
Bioserenity SAS |
CARDIOSKIN |
08/11/2018 |
K172311 |
Biotricity Inc. |
BioFlux Device |
12/15/2017 |
K040942 |
BIOWATCH MEDICAL, INC. |
VST3 |
09/15/2004 |
K982034 |
BLAKBAG, LTD., DIVISION OF COHERENT SYSTEMS |
E-FAX SYSTEM |
02/19/1999 |
K981394 |
BRAEMAR CORP. |
BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 |
09/28/1998 |
K963725 |
CARD GUARD LTD. |
MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED) |
09/10/1997 |
K963811 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE |
12/04/1996 |
K954350 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CARD GUARD MODEL CG-6500 |
09/10/1996 |
K000225 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306 |
02/11/2000 |
K990478 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CARD GUARD, MODEL CG-6550 |
08/31/1999 |
K964836 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CARD GUARD, MODEL CG-7100 |
07/28/1997 |
K994009 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CG-2100 ECG TRANSMITTER |
12/21/1999 |
K012223 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CG-2211 SELFCHECK ECG TRANSMITTER |
09/10/2001 |
K012187 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CG-3250 MINIRECEIVER |
08/14/2001 |
K023689 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM |
01/17/2003 |
K060911 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CG-6108 ARRHYTHMIA ECG EVENT RECORDER |
08/22/2006 |
K993799 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CG-7000DX ECG RECORDER/TRANSMITTER |
12/10/1999 |
K052556 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CG-7000DX-BT ECG RECORDER/TRANSMITTER |
01/09/2006 |
K992696 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ECG MINIMONITOR, MODEL CG-5000 |
10/07/1999 |
K083174 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
HEALTHEPOD |
12/17/2009 |
K983026 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000 |
12/02/1998 |
K003220 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
PERSONAL ECG TRANSMITTER, MODEL CG-6550 |
11/08/2000 |
K050940 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
PMP4 MEDICAL WEB CENTER |
07/01/2005 |
K042254 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
PMP4 SELFCHECK ECG |
01/13/2005 |
K991307 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
TELEMEDICINE 2000 |
06/14/1999 |
K992164 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
TELEMEDICINE 2000 |
08/30/1999 |
K013175 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
TM2000 EASYTRACE PLUS RECEIVING CENTER |
10/30/2001 |
K013879 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
TM2000, MODEL 1 |
02/01/2002 |
K024365 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
TM2005 PERSONAL MEDICAL PHONE CENTER |
01/15/2003 |
K170506 |
Cardiac Designs, Inc. |
ECG Check - Universal, ECG Check - Universal Plus |
10/02/2017 |
K122184 |
CARDIAC DESIGNS, LLC |
ECG CHECK |
02/14/2013 |
K954163 |
CARDIAC EVALUATION CENTER, INC. |
RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER |
07/11/1996 |
K181310 |
CardioComm Solutions, Inc. |
HeartCheck Cardi Beat ECG Monitor with GEMS Mobile |
02/22/2019 |
K172801 |
Cardiomedix, Inc. |
ECG SENTINEL System |
10/18/2017 |
K050951 |
CIBERNET SYSTEMS CORP. |
MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370 |
07/19/2005 |
K182040 |
Coala Life AB |
Coala Heart Monitor |
02/08/2019 |
K133703 |
COMMWELL R&D LTD. |
PHYSIOGLOVE ET SYSTEM |
08/18/2014 |
K082077 |
CORSCIENCE GMBH & CO. KG |
BT3/6, BT12 |
09/02/2008 |
K020534 |
CYBERNET MEDICAL |
MEDSTAR SYSTEM, MODELS 533-300 |
02/11/2003 |
K971650 |
DATA CRITICAL CORP. |
RHYTHMSTAT XL |
12/04/1997 |
K042022 |
DATRIX, INC. DBA OF JON BARRON, INC. |
E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER |
08/12/2004 |
K971696 |
DEL MAR AVIONICS |
SENTINEL RECORDER, MODELS 471/472 |
12/30/1997 |
K051960 |
DEL MAR REYNOLDS MEDICAL, LTD. |
CARDIONAVIGATOR + |
08/19/2005 |
K062397 |
DEL MAR REYNOLDS MEDICAL, LTD. |
SENTINEL |
01/25/2007 |
K072385 |
DIAGNOSTIC DEVICES PTY LTD |
HEARTEVENT, MODEL AT |
01/11/2008 |
K193296 |
eCordum, Inc. |
eCordum Cardiac Monitor (eCordum CM) |
10/30/2020 |
K121628 |
EPI MOBILE HEALTH SOLUTIONS (S) PTE LTD |
EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) |
06/25/2013 |
K173589 |
G-Medical Innovations Ltd. |
Prizma |
11/30/2018 |
K170181 |
G-Medical Innovations Ltd. |
Prizma |
09/01/2017 |
K012012 |
H&C MEDICAL DEVICES SPA |
ECG HOME |
01/17/2002 |
K973267 |
HDS MEDICAL, INC. |
TTM5000 TELEPHONIC EKG MONITOR |
01/29/1998 |
K142476 |
HealthWatch Ltd. |
Master Caution Device MCD |
02/17/2015 |
K963904 |
HEART ALERT, INC. |
P.H.D. - PERSONAL HEART DEVICE MODEL 5258 |
05/15/1997 |
K973863 |
HI-TRONICS DESIGNS, INC. |
MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR |
01/02/1998 |
K010945 |
INSTROMEDIX |
HEARTCARD, MODEL 5258 |
06/12/2001 |
K955060 |
INSTROMEDIX, INC. |
ACCELERATED TRANSMISSION PROTOCOL |
04/08/1996 |
K964036 |
INSTROMEDIX, INC. |
CARDIOMAGIC 2000 SOFTWARE |
07/18/1997 |
K951096 |
INSTROMEDIX, INC. |
LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER |
01/16/1996 |
K081471 |
IRHYTHM TECHNOLOGIES, INC. |
ECARD AND CCARD |
06/24/2008 |
K052767 |
LECHNOLOGIES RESEARCH INC. |
AFIBALERT ATRIAL FIBRILLATION DETECTOR |
06/23/2006 |
K201208 |
LIVMOR |
Halo AF Detection System |
09/23/2020 |
K130878 |
MAKROMED, INC. |
CLOUDEKG |
04/04/2014 |
K060297 |
MEDICAL MONITORS LTD |
PEPER |
08/02/2006 |
K030218 |
MEDICAL MONITORS PTY., LTD. |
PER, MODEL MEMO |
06/23/2003 |
K981119 |
MEDICOMP, INC. |
CARDIOPAL MODEL NUMBER PM20 |
10/14/1998 |
K131699 |
MEGA ELECTRONICS LTD. |
EMOTION ECG MOBILE |
11/26/2013 |
K143032 |
MEGA ELECTRONICS LTD. |
eMotion Faros ECG Mobile |
03/29/2015 |
K983582 |
MERDIAN MEDICAL TECHNOLOGIES LTD. |
CARDIOBEEPER CB250 |
11/13/1998 |
K010794 |
MERIDIAN MEDICAL TECHNOLOGIES LTD. |
BRIDGE III RECEIVER |
05/10/2001 |
K002310 |
MERIDIAN MEDICAL TECHNOLOGIES LTD. |
CARDIOBEEPER CB12/12, MODEL CB12/12 |
10/25/2000 |
K965101 |
MERIDIAN MEDICAL TECHNOLOGIES, INC. |
CARDIOBEEPER CB-12L |
03/17/1997 |
K970305 |
MICROMEDICAL, INC. |
PRINTER INTERFACE |
08/15/1997 |
K161431 |
Nanowear Inc. |
SimplECG |
11/30/2016 |
K201669 |
Nanowear Inc. |
SimpleSENSE |
11/06/2020 |
K212160 |
Nanowear Inc. |
SimpleSENSE Platform |
09/22/2021 |
K001091 |
NEXT MILLENNIUM SOFTWARE SOLUTIONS, INC. |
CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01 |
08/10/2000 |
K973141 |
PACEART, INC. |
HEART ACCESS PLUS CARDIAC EVENT RECORDER |
11/12/1997 |
K952065 |
PACEART, INC. |
PACEART CARDIOVOICE |
01/16/1996 |
K982090 |
PACEART, INC. |
PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM |
01/26/1999 |
K012407 |
PACEART, INC. |
PACEART TX3 CARDIAC EVENT RECORDER |
08/14/2001 |
K061977 |
PINMED, INC |
PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES |
07/21/2006 |
K093976 |
PROTEUS BIOMEDICAL, INC. |
RAISIN PERSONAL MONITOR |
03/25/2010 |
K173872 |
Qompium nv |
FibriCheck |
09/28/2018 |
K180157 |
QT Medical, Inc. |
QT ECG |
05/04/2018 |
K220795 |
QT Medical, Inc. |
QT ECG |
09/26/2022 |
K010436 |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 |
05/14/2001 |
K033410 |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 |
03/05/2004 |
K082718 |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
TEMPUSIC PATIENT MONITOR |
10/10/2008 |
K972649 |
REYNOLDS MEDICAL LTD. |
CARDIOCALL CARDIAC EVENT RECORDER |
12/04/1997 |
K011345 |
REYNOLDS MEDICAL LTD. |
CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM |
07/20/2001 |
K991211 |
REYNOLDS MEDICAL LTD. |
EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM |
07/08/1999 |
K141813 |
RHYTHMEDIX, LLC |
RHYTHMSTAR SYSTEM |
08/05/2014 |
K992772 |
RLT MEDICAL ASSOC., INC. |
CARDIOPHONICS 1000 MEMORY MONITOR |
09/17/1999 |
K020213 |
ROZINN ELECTRONICS, INC. |
NETLINK/NETSCAN |
04/05/2002 |
K061780 |
ROZINN ELECTRONICS, INC. |
TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + |
09/15/2006 |
K222842 |
Shandong CoreCare Technology Limited |
V-Patch Cardiac Monitor |
10/20/2022 |
K080047 |
SHL TELEMEDICINE INTERNATIONAL LTD. |
CARDIOSEN'C |
07/11/2008 |
K063609 |
SHL TELEMEDICINE INTERNATIONAL LTD. |
RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER |
09/12/2007 |
K113514 |
SHL TELEMEDICINE INTERNATIONAL LTD. |
SMARTHEART |
02/22/2012 |
K071228 |
SIGNALIFE, INC. |
FIDELITY 200 CARDIAC EVENT RECORDER |
11/21/2007 |
K083630 |
TELOVITAL GMBH TELEMEDIZIN |
CLUE MEDICAL AND CLUE MEDICAL BASIC |
04/23/2009 |
K031229 |
TELZUIT TECHNOLOGIES, INC. |
TELZUIT CARDIAC MONITORING SYSTEM |
07/09/2003 |
K053378 |
TMS TELEMEDIZINISCHE SYSTEME GMBH |
LOOP RECORDER VITAPHONE, 3100 SERIES |
02/23/2006 |
K050670 |
TMS TELEMEDIZINISCHE SYSTEME GMBH |
SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS |
03/30/2005 |
K001634 |
TZ MEDICAL, INC. |
CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 |
12/21/2000 |
K982228 |
TZ MEDICAL, INC. |
FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25 |
01/14/1999 |
K964888 |
TZ MEDICAL, INC. |
HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II |
02/28/1997 |
K980624 |
UNIVERSAL MEDICAL, INC. |
CARDIOSTATION |
05/11/1998 |
K071130 |
UNIVERSAL MEDICAL, INC. |
HEARTRAK AF |
05/14/2008 |
K033451 |
UNIVERSAL MEDICAL, INC. |
HEARTRAK SMART AT/HEARTRAK SMART2 |
02/05/2004 |
K083535 |
UNIVERSAL MEDICAL, INC. |
HEARTRAK SMART ECAT |
12/15/2008 |
K960499 |
UNIVERSAL MEDICAL, INC. |
HEARTRAK XL |
08/06/1996 |
K954495 |
UNIVERSAL MEDICAL, INC. |
PACETRAK PLUS |
04/22/1996 |
K182456 |
Verily Life Sciences LLC |
Study Watch |
01/17/2019 |
K192415 |
Verily Life Sciences LLC |
Study Watch with Irregular Pulse Monitor |
01/17/2020 |
K213357 |
Verily Life Sciences LLC |
Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor |
07/19/2022 |
K963375 |
VISION ELECTRONICS |
CARDIACMONITOR |
02/28/1997 |
K962937 |
VISION ELECTRONICS |
CARDIO TEAM II |
04/10/1997 |
K151013 |
Vitasystems GmbH |
Vitaphone Tele ECG Loop Recorder |
04/30/2015 |
K100383 |
VITASYSTEMS GMBH |
VITAPHONE. MODEL 100 BT |
04/20/2010 |
K183704 |
VivaQuant Inc. |
RX-1 Rhythm Express Remote Cardiac Monitoring System |
02/16/2019 |
K041308 |
WEBVMC, LLC |
REMOTENURSE PATIENT MONITORING SYSTEM |
06/28/2004 |
K002004 |
ZYMED MEDICAL INSTRUMENTATION |
ZYBIT |
09/21/2000 |