FDA Product Code
FDA Product Code DSH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2800
510(k) Clearances — 195 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | 2026-07-09 | Traditional | PDF ↗ |
| K252389 | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | Smwmed, Inc. | 2026-04-23 | Traditional | PDF ↗ |
| K253293 | VitaloJAK Clinic (Model 7100) | Vitalograph , Ltd. | 2025-12-03 | Special | PDF ↗ |
| K243650 | Zio® monitor (DFG0001) | iRhythm Technologies, Inc. | 2025-08-15 | Traditional | PDF ↗ |
| K243603 | AeviceMD | Aevice Health Pte. , Ltd. | 2025-05-05 | Traditional | PDF ↗ |
| K242583 | AT-Patch (ATP-C130/ATP-C70) | Atsens Co., Ltd. | 2025-05-02 | Traditional | PDF ↗ |
| K232670 | HiCardi+ H100 | MEZOO Co., Ltd. | 2024-09-20 | Traditional | PDF ↗ |
| K233906 | S-Patch (S-Patch ExL) | Wellysis Corp. | 2024-02-16 | Special | PDF ↗ |
| K231104 | ABPMpro | Somnomedics GmbH | 2023-11-27 | Traditional | PDF ↗ |
| K233110 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2023-11-22 | Traditional | PDF ↗ |
| K230184 | Holter ECG and ABP System | Edan Instruments, Inc. | 2023-09-25 | Traditional | PDF ↗ |
| K231289 | S-Patch Ex Wearable ECG Patch | Wellysis Corp. | 2023-08-30 | Traditional | PDF ↗ |
| K223382 | AeviceMD | Aevice Health Pte. , Ltd. | 2023-07-07 | Traditional | PDF ↗ |
| K223049 | CardioSTAT® ECG Test Solution | Icentia, Inc. | 2023-03-22 | Traditional | PDF ↗ |
| K214073 | eWave Monitor | Wearlinq, Inc. | 2022-10-20 | Traditional | PDF ↗ |
| K203638 | AT-Patch ECG Analysis System | Atsens Co., Ltd. | 2022-10-12 | Traditional | PDF ↗ |
| K210179 | QOCA Portable ECG Monitoring Device | Quanta Computer, Inc. | 2022-08-02 | Traditional | PDF ↗ |
| K220893 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs, Inc. | 2022-04-27 | Traditional | PDF ↗ |
| K203168 | LifeLens Wireless ECG Monitor | LifeLens Technologies, Inc. | 2021-07-20 | Traditional | PDF ↗ |
| K202359 | Zio Monitor | iRhythm Technologies, Inc. | 2021-05-21 | Traditional | PDF ↗ |
| K201644 | QardioCore | Qardio, Inc. | 2021-02-28 | Traditional | PDF ↗ |
| K210036 | Carnation Ambulatory Monitor (CAM) | Bardy Diagnostics, Inc. | 2021-02-05 | Special | PDF ↗ |
| K202456 | M5 Recorder | Global Instrumentation, LLC | 2020-12-29 | Abbreviated | PDF ↗ |
| K201077 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs | 2020-12-20 | Traditional | PDF ↗ |
| K201040 | Bioflux Software II | Biotricity | 2020-07-29 | Traditional | PDF ↗ |
| K200870 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2020-05-01 | Special | PDF ↗ |
| K192556 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2019-10-17 | Special | PDF ↗ |
| K191471 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2019-08-30 | Special | PDF ↗ |
| K191000 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2019-05-16 | Special | PDF ↗ |
| K173461 | ECG recorder and Arrhythmia Detector | Smart Solutions Technologies SL | 2018-08-03 | Traditional | PDF ↗ |
| K172862 | Portable ECG Monitor (ECG3) | Andon Health Co, Ltd. | 2018-07-24 | Traditional | PDF ↗ |
| K171410 | ePatch | Braemar Manufacturing, LLC | 2018-01-04 | Traditional | PDF ↗ |
| K171936 | Peerbridge Cor(TM) System | Peerbridge Health, Inc. | 2017-09-27 | Traditional | PDF ↗ |
| K162503 | Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software | Cardiac Insight, Inc. | 2017-03-24 | Traditional | PDF ↗ |
| K163535 | my Patch sl | Dms-Service, LLC | 2017-02-22 | Special | PDF ↗ |
| K162571 | Bioflux Software | Biotricity, Inc. | 2016-10-13 | Traditional | PDF ↗ |
| K160704 | myPatch-s | Dms-Service, LLC | 2016-07-15 | Traditional | PDF ↗ |
| K142468 | Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System | Cardiac Insight, Inc. | 2015-07-11 | Traditional | PDF ↗ |
| K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015-06-19 | Traditional | PDF ↗ |
| K143067 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2014-12-22 | Traditional | PDF ↗ |
| K131190 | MYPATCH | Dms-Service, LLC | 2013-10-29 | Traditional | PDF ↗ |
| K130288 | STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE | Cardiac Insight, Inc. | 2013-05-29 | Traditional | PDF ↗ |
| K121319 | ZIO PATCH | iRhythm Technologies, Inc. | 2012-07-18 | Traditional | PDF ↗ |
| K113862 | ZIO PATCH | iRhythm Technologies, Inc. | 2012-02-06 | Special | PDF ↗ |
| K113176 | MYSENSE HEART | Cardiac Science Corporation | 2011-12-21 | Traditional | PDF ↗ |
| K110525 | VITALOGRAPH MODEL 7100 - VITALOJAK | Vitalograph (Ireland) , Ltd. | 2011-11-23 | Traditional | PDF ↗ |
| K111320 | GLOBALCARDIO | Cardiocomm Solutions, Inc. | 2011-10-07 | Traditional | PDF ↗ |
| K111745 | KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER | Card Guard Scientific Survival , Ltd. | 2011-08-01 | Special | PDF ↗ |
| K111180 | VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY | Vasomedical, Inc. | 2011-06-28 | Special | PDF ↗ |
| K111096 | VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY | Vasomedical, Inc. | 2011-06-24 | Special | PDF ↗ |
| K101022 | PULMOTRACK 5050 WHOLTER, MODEL 5050 | Karmelsonix | 2010-07-09 | Traditional | PDF ↗ |
| K092785 | COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 | Vasomedical, Inc. | 2010-04-02 | Traditional | PDF ↗ |
| K091505 | COR12+ | Viasys Healthcare GmbH | 2009-06-10 | Traditional | PDF ↗ |
| K090363 | ZIO PATCH, MODEL Z100 | iRhythm Technologies, Inc. | 2009-05-08 | Traditional | PDF ↗ |
| K083820 | VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C | Vasomedical, Inc. | 2009-04-01 | Traditional | PDF ↗ |
| K073152 | PC-180 / PRINCE 180 EASY ECG MONITOR | Shenzhen Creative Industry Co., Ltd. | 2008-01-10 | Traditional | PDF ↗ |
| K070818 | MEDILOGAR4, MEDILOGAR12 | Tom Medical Entwicklungs GmbH | 2007-04-06 | Traditional | PDF ↗ |
| K062007 | DMS 300-7 | Diagnostic Monitoring Software | 2006-08-16 | Special | PDF ↗ |
| K050896 | H12+ HOLTER RECORDER | Mortara Instrument, Inc. | 2005-08-24 | Traditional | PDF ↗ |
| K033037 | MODIFICATION TO GLOBALCARDIO | Cardiocomm Solutions, Inc. | 2003-10-31 | Traditional | PDF ↗ |
| K032103 | PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A | Philips Medical Systems | 2003-07-22 | Special | PDF ↗ |
| K022540 | CARDIO ID+(RZ153+) | Rozinn Electronics, Inc. | 2002-10-24 | Traditional | PDF ↗ |
| K022297 | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) | Cardiocomm Solutions, Inc. | 2002-09-27 | Special | PDF ↗ |
| K020825 | KING OF HEARTS EXPRESS + AF MONITOR | Card Guard Scientific Survival , Ltd. | 2002-04-05 | Special | PDF ↗ |
| K013354 | GLOBALCARDIO | Cardiocomm Solutions, Inc. | 2002-01-31 | Traditional | PDF ↗ |
| K004007 | DR180+OXY | North East Monitoring, Inc. | 2001-01-25 | Special | PDF ↗ |
| K001025 | LIFECARD CF COMPACT RECORDER | Reynolds Medical , Ltd. | 2000-04-19 | Special | PDF ↗ |
| K982448 | CARDIOLIGHT | Capintec, Inc. | 1999-06-11 | Traditional | PDF ↗ |
| K990027 | OMNICORDER, MODEL 464 | Del Mar Avionics | 1999-02-09 | Abbreviated | PDF ↗ |
| K982384 | MERCATOR | Harley Street Software , Ltd. | 1999-01-27 | Traditional | PDF ↗ |
| K973735 | MICROVIT MT-100 | Schiller America, Inc. | 1998-08-25 | Traditional | PDF ↗ |
| K974420 | M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION | Hewlett-Packard Co. | 1998-02-19 | Traditional | PDF ↗ |
| K971670 | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER | Galix Biomedical Instrumentation, Inc. | 1998-01-29 | Traditional | PDF ↗ |
| K970298 | DM-400 HOLTER ECG CASSETTE RECORDER | Diagnostic Monitoring | 1997-08-20 | Traditional | PDF ↗ |
| K971604 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP | Alexander Mfg. Co. | 1997-07-28 | Traditional | PDF ↗ |
| K970902 | MEDILOG FD4 | Oxford Instruments Medical Systems | 1997-05-05 | Traditional | PDF ↗ |
| K963174 | HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) | Del Mar Avionics | 1997-03-13 | Traditional | PDF ↗ |
| K944180 | MODEL 700 | Memtec Corp. | 1997-03-07 | Traditional | PDF ↗ |
| K960925 | NORTHEAST MONITORING DR180 | North East Monitoring, Inc. | 1996-07-31 | Traditional | PDF ↗ |
| K950854 | VITALOGRAPH 2110 SOFTWARE INTERFACE | Vitalograph , Ltd. | 1995-10-12 | Traditional | PDF ↗ |
| K950020 | HOLTER PACERCORDER(R) | Del Mar Avionics | 1995-08-17 | Traditional | PDF ↗ |
| K951605 | SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM | Spacelabs, Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K943862 | SONICAID MODEL MR-63 AMBULATORY ECG RECORDER | Oxford Instruments Medical Systems | 1995-06-07 | Traditional | PDF ↗ |
| K942653 | HOLTER SSR DIGICORDER(TM) | Del Mar Avionics | 1995-05-10 | Traditional | PDF ↗ |
| K945130 | BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER | Braemar Corp. | 1995-04-12 | Traditional | PDF ↗ |
| K942781 | DIGITAL HOLTER RECORDER | Agilent Technologies | 1995-01-24 | Traditional | PDF ↗ |
| K942862 | HEARTPRINT | Medata, Inc. | 1995-01-18 | Traditional | PDF ↗ |
| K943278 | TRACKER 2/TRACKER 3 HOLTER RECORDER | Reynolds Medical , Ltd. | 1994-10-20 | Traditional | PDF ↗ |
| K942438 | ALTAIR 6100 CASSETTE RECORDER | Burdick, Inc. | 1994-08-05 | Traditional | PDF ↗ |
| K923664 | SCOLE 300 ECG RECORDER | Scole Engineering Co. | 1994-01-13 | Traditional | PDF ↗ |
| K934660 | R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211 | R & D Batteries, Inc. | 1993-12-03 | Traditional | PDF ↗ |
| K930894 | MULTITRAK-PLUS | Zymed Medical Instrumentation | 1993-11-01 | Traditional | PDF ↗ |
| K932929 | HRV 4000EM | All-Tronics Medical Systems | 1993-09-09 | Traditional | PDF ↗ |
| K920572 | UNISCAN 24 ECG ROCORDER | Uniscan , Ltd. | 1992-04-06 | Traditional | PDF ↗ |
| K921068 | GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 | Datrix | 1992-03-30 | Traditional | PDF ↗ |
| K913600 | WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM | Ralin Laboratories, Inc. | 1991-10-16 | Traditional | PDF ↗ |
| K910884 | CARD GUARD, MODELS CG-6000 & CG-7000 | Card Guard Scientific Survival , Ltd. | 1991-10-16 | Traditional | PDF ↗ |
| K913038 | SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION | Spacelabs, Inc. | 1991-10-04 | Traditional | PDF ↗ |
| K904176 | GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER | Galix Instrumentacion Biomedica | 1991-09-20 | Traditional | PDF ↗ |
| K904177 | GALIX MA-6C HOLTER CASSETTE RECORDER | Galix Instrumentacion Biomedica | 1991-09-20 | Traditional | PDF ↗ |
Product code DSH · Class II · Cardiovascular. Data: openFDA.