FDA 510(k) Applications for Medical Device Product Code "DXH"
(Transmitters And Receivers, Electrocardiograph, Telephone)
| 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 |
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