FDA Product Code
FDA Product Code DXH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2920
510(k) Clearances — 297 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250233 | PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | 2026-02-13 | Traditional | PDF ↗ |
| K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | Heartbeam, Inc. | 2025-12-08 | Traditional | PDF ↗ |
| K243438 | MEMO Patch M (MPT-E08R-UNC01) | Huinno Co., Ltd. | 2025-12-05 | Traditional | PDF ↗ |
| K243981 | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | 2025-11-18 | Traditional | PDF ↗ |
| K243003 | VitalSigns 1-Lead Holter (VSH101) | VitalSigns Technology Co., Ltd. | 2025-06-17 | Traditional | PDF ↗ |
| K233521 | QT ECG (QTERD100) | QT Medical, Inc. | 2023-12-06 | Special | PDF ↗ |
| K222842 | V-Patch Cardiac Monitor | Shandong Corecare Technology Limited | 2022-10-20 | Traditional | PDF ↗ |
| K220795 | QT ECG | QT Medical, Inc. | 2022-09-26 | Traditional | PDF ↗ |
| K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | 2022-07-19 | Traditional | PDF ↗ |
| K220350 | KardiaMobile 6L | AliveCor, Inc. | 2022-05-25 | Traditional | PDF ↗ |
| K211668 | KardiaMobile Card | AliveCor, Inc. | 2021-11-30 | Special | PDF ↗ |
| K212160 | SimpleSENSE Platform | Nanowear, Inc. | 2021-09-22 | Special | PDF ↗ |
| K210753 | KardiaMobile 6L | AliveCor, Inc. | 2021-06-30 | Traditional | PDF ↗ |
| K201669 | SimpleSENSE | Nanowear, Inc. | 2020-11-06 | Traditional | PDF ↗ |
| K193296 | eCordum Cardiac Monitor (eCordum CM) | Ecordum, Inc. | 2020-10-30 | Traditional | PDF ↗ |
| K201208 | Halo AF Detection System | Livmor | 2020-09-23 | Traditional | PDF ↗ |
| K191406 | KardiaMobile, KardiaStation | AliveCor, Inc. | 2020-01-24 | Traditional | PDF ↗ |
| K192415 | Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | 2020-01-17 | Traditional | PDF ↗ |
| K183319 | Triangle System | AliveCor, Inc. | 2019-05-10 | Traditional | PDF ↗ |
| K182396 | KardiaMobile, KardiaStation | AliveCor, Inc. | 2019-04-12 | Traditional | PDF ↗ |
| K181310 | HeartCheck Cardi Beat ECG Monitor with GEMS Mobile | Cardiocomm Solutions, Inc. | 2019-02-22 | Traditional | PDF ↗ |
| K183704 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. | 2019-02-16 | Traditional | PDF ↗ |
| K182040 | Coala Heart Monitor | Coala Life AB | 2019-02-08 | Traditional | PDF ↗ |
| K182456 | Study Watch | Verily Life Sciences, LLC | 2019-01-17 | Traditional | PDF ↗ |
| K173589 | Prizma | G-Medical Innovations , Ltd. | 2018-11-30 | Traditional | PDF ↗ |
| K173872 | FibriCheck | Qompium NV | 2018-09-28 | Traditional | PDF ↗ |
| K173248 | CARDIOSKIN | Bioserenity Sas | 2018-08-11 | Traditional | PDF ↗ |
| K180157 | QT ECG | QT Medical, Inc. | 2018-05-04 | Traditional | PDF ↗ |
| K172311 | BioFlux Device | Biotricity, Inc. | 2017-12-15 | Traditional | PDF ↗ |
| K171816 | Kardia Band System | AliveCor, Inc. | 2017-11-16 | Traditional | PDF ↗ |
| K172801 | ECG SENTINEL System | Cardiomedix, Inc. | 2017-10-18 | Traditional | PDF ↗ |
| K170506 | ECG Check - Universal, ECG Check - Universal Plus | Cardiac Designs, Inc. | 2017-10-02 | Traditional | PDF ↗ |
| K170181 | Prizma | G-Medical Innovations , Ltd. | 2017-09-01 | Traditional | PDF ↗ |
| K161431 | SimplECG | Nanowear, Inc. | 2016-11-30 | Traditional | PDF ↗ |
| K151013 | Vitaphone Tele ECG Loop Recorder | Vitasystems GmbH | 2015-04-30 | Traditional | PDF ↗ |
| K143032 | eMotion Faros ECG Mobile | Mega Electronics , Ltd. | 2015-03-29 | Traditional | PDF ↗ |
| K142476 | Master Caution Device MCD | Healthwatch , Ltd. | 2015-02-17 | Traditional | PDF ↗ |
| K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015-01-27 | Traditional | PDF ↗ |
| K142672 | AliveCor Heart Monitor | AliveCor, Inc. | 2014-12-03 | Special | PDF ↗ |
| K133703 | PHYSIOGLOVE ET SYSTEM | Commwell R&D , Ltd. | 2014-08-18 | Traditional | PDF ↗ |
| K140933 | ALIVECOR HEART MONITOR | AliveCor, Inc. | 2014-08-15 | Traditional | PDF ↗ |
| K141813 | RHYTHMSTAR SYSTEM | RhythMedix, LLC | 2014-08-05 | Traditional | PDF ↗ |
| K130878 | CLOUDEKG | Makromed, Inc. | 2014-04-04 | Traditional | PDF ↗ |
| K132206 | MELYS ATRIAL FIBRILLATION SCREENING MONITOR | Advanced Fluidics, LLC | 2014-03-19 | Traditional | PDF ↗ |
| K131699 | EMOTION ECG MOBILE | Mega Electronics , Ltd. | 2013-11-26 | Traditional | PDF ↗ |
| K121628 | EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013-06-25 | Traditional | PDF ↗ |
| K122184 | ECG CHECK | Cardiac Designs, LLC | 2013-02-14 | Traditional | PDF ↗ |
| K113514 | SMARTHEART | Shl Telemedicine International , Ltd. | 2012-02-22 | Traditional | PDF ↗ |
| K100383 | VITAPHONE. MODEL 100 BT | Vitasystems GmbH | 2010-04-20 | Traditional | PDF ↗ |
| K093976 | RAISIN PERSONAL MONITOR | Proteus Biomedical, Inc. | 2010-03-25 | Traditional | PDF ↗ |
| K083174 | HEALTHEPOD | Card Guard Scientific Survival , Ltd. | 2009-12-17 | Traditional | PDF ↗ |
| K083630 | CLUE MEDICAL AND CLUE MEDICAL BASIC | Telovital GmbH Telemedizin | 2009-04-23 | Special | PDF ↗ |
| K083535 | HEARTRAK SMART ECAT | Universal Medical, Inc. | 2008-12-15 | Traditional | PDF ↗ |
| K082718 | TEMPUSIC PATIENT MONITOR | Remote Diagnostic Technologies , Ltd. | 2008-10-10 | Traditional | PDF ↗ |
| K082077 | BT3/6, BT12 | Corscience GmbH & Co. KG | 2008-09-02 | Traditional | PDF ↗ |
| K080047 | CARDIOSEN'C | Shl Telemedicine International , Ltd. | 2008-07-11 | Traditional | PDF ↗ |
| K081471 | ECARD AND CCARD | iRhythm Technologies, Inc. | 2008-06-24 | Traditional | PDF ↗ |
| K071130 | HEARTRAK AF | Universal Medical, Inc. | 2008-05-14 | Abbreviated | PDF ↗ |
| K072385 | HEARTEVENT, MODEL AT | Diagnostic Devices Pty, Ltd. | 2008-01-11 | Traditional | PDF ↗ |
| K071228 | FIDELITY 200 CARDIAC EVENT RECORDER | Signalife, Inc. | 2007-11-21 | Abbreviated | PDF ↗ |
| K063609 | RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER | Shl Telemedicine International , Ltd. | 2007-09-12 | Traditional | PDF ↗ |
| K062397 | SENTINEL | Del Mar Reynolds Medical, Ltd. | 2007-01-25 | Special | PDF ↗ |
| K061780 | TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + | Rozinn Electronics, Inc. | 2006-09-15 | Traditional | PDF ↗ |
| K060911 | CG-6108 ARRHYTHMIA ECG EVENT RECORDER | Card Guard Scientific Survival , Ltd. | 2006-08-22 | Special | PDF ↗ |
| K060297 | PEPER | Medical Monitors, Ltd. | 2006-08-02 | Traditional | PDF ↗ |
| K061977 | PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES | Pinmed, Inc. | 2006-07-21 | Traditional | PDF ↗ |
| K052767 | AFIBALERT ATRIAL FIBRILLATION DETECTOR | Lechnologies Research, Inc. | 2006-06-23 | Traditional | PDF ↗ |
| K053378 | LOOP RECORDER VITAPHONE, 3100 SERIES | Tms Telemedizinische Systeme GmbH | 2006-02-23 | Traditional | PDF ↗ |
| K052556 | CG-7000DX-BT ECG RECORDER/TRANSMITTER | Card Guard Scientific Survival , Ltd. | 2006-01-09 | Special | PDF ↗ |
| K051544 | VITALCAREGIVING SYSTEM | Advanced Monitoring Caregiving, Inc. | 2005-10-07 | Traditional | PDF ↗ |
| K051960 | CARDIONAVIGATOR + | Del Mar Reynolds Medical, Ltd. | 2005-08-19 | Special | PDF ↗ |
| K050951 | MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370 | Cibernet Systems Corp. | 2005-07-19 | Traditional | PDF ↗ |
| K050940 | PMP4 MEDICAL WEB CENTER | Card Guard Scientific Survival , Ltd. | 2005-07-01 | Traditional | PDF ↗ |
| K050670 | SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS | Tms Telemedizinische Systeme GmbH | 2005-03-30 | Traditional | PDF ↗ |
| K042254 | PMP4 SELFCHECK ECG | Card Guard Scientific Survival , Ltd. | 2005-01-13 | Special | PDF ↗ |
| K040942 | VST3 | Biowatch Medical, Inc. | 2004-09-15 | Traditional | PDF ↗ |
| K042022 | E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER | Datrix, Inc. Dba of Jon Barron, Inc. | 2004-08-12 | Traditional | PDF ↗ |
| K041308 | REMOTENURSE PATIENT MONITORING SYSTEM | Webvmc, LLC | 2004-06-28 | Abbreviated | PDF ↗ |
| K033410 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 | Remote Diagnostic Technologies , Ltd. | 2004-03-05 | Traditional | PDF ↗ |
| K033451 | HEARTRAK SMART AT/HEARTRAK SMART2 | Universal Medical, Inc. | 2004-02-05 | Special | PDF ↗ |
| K032736 | HEART 2006 | Aerotel Medical Systems (1998) , Ltd. | 2003-10-03 | Special | PDF ↗ |
| K031229 | TELZUIT CARDIAC MONITORING SYSTEM | Telzuit Technologies, Inc. | 2003-07-09 | Abbreviated | PDF ↗ |
| K030218 | PER, MODEL MEMO | Medical Monitors Pty., Ltd. | 2003-06-23 | Traditional | PDF ↗ |
| K020534 | MEDSTAR SYSTEM, MODELS 533-300 | Cybernet Medical | 2003-02-11 | Traditional | PDF ↗ |
| K023689 | CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM | Card Guard Scientific Survival , Ltd. | 2003-01-17 | Traditional | PDF ↗ |
| K024365 | TM2005 PERSONAL MEDICAL PHONE CENTER | Card Guard Scientific Survival , Ltd. | 2003-01-15 | Special | PDF ↗ |
| K023418 | HEARTONE EVENT RECORDER AND TRANSMITTER | Aerotel Medical Systems (1998) , Ltd. | 2002-11-06 | Special | PDF ↗ |
| K022073 | HEARTLINE RECEIVING STATION | Aerotel Medical Systems (1998) , Ltd. | 2002-07-24 | Special | PDF ↗ |
| K020213 | NETLINK/NETSCAN | Rozinn Electronics, Inc. | 2002-04-05 | Traditional | PDF ↗ |
| K013879 | TM2000, MODEL 1 | Card Guard Scientific Survival , Ltd. | 2002-02-01 | Traditional | PDF ↗ |
| K012012 | ECG HOME | H&C Medical Devices Spa | 2002-01-17 | Abbreviated | PDF ↗ |
| K013175 | TM2000 EASYTRACE PLUS RECEIVING CENTER | Card Guard Scientific Survival , Ltd. | 2001-10-30 | Special | PDF ↗ |
| K012223 | CG-2211 SELFCHECK ECG TRANSMITTER | Card Guard Scientific Survival , Ltd. | 2001-09-10 | Traditional | PDF ↗ |
| K012187 | CG-3250 MINIRECEIVER | Card Guard Scientific Survival , Ltd. | 2001-08-14 | Special | PDF ↗ |
| K012407 | PACEART TX3 CARDIAC EVENT RECORDER | Paceart, Inc. | 2001-08-14 | Special | PDF ↗ |
| K011345 | CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM | Reynolds Medical , Ltd. | 2001-07-20 | Traditional | PDF ↗ |
| K010945 | HEARTCARD, MODEL 5258 | Instromedix | 2001-06-12 | Traditional | PDF ↗ |
| K010791 | REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) | Adsis , Ltd. | 2001-06-08 | Traditional | PDF ↗ |
| K010436 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011 | Remote Diagnostic Technologies , Ltd. | 2001-05-14 | Traditional | PDF ↗ |
| K010794 | BRIDGE III RECEIVER | Meridian Medical Technologies , Ltd. | 2001-05-10 | Traditional | PDF ↗ |
Product code DXH · Class II · Cardiovascular. Data: openFDA.