FDA 510(k) Applications for Medical Device Product Code "DSH"
(Recorder, Magnetic Tape, Medical)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K223382 | Aevice Health Pte. Ltd. | AeviceMD | 07/07/2023 |
| K243603 | Aevice Health Pte. Ltd. | AeviceMD | 05/05/2025 |
| K971604 | ALEXANDER MFG. CO. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP | 07/28/1997 |
| K172862 | Andon Health Co., Ltd. | Portable ECG Monitor (ECG3) | 07/24/2018 |
| K203638 | ATsens Co., Ltd | AT-Patch ECG Analysis System | 10/12/2022 |
| K242583 | ATsens Co.,Ltd. | AT-Patch (ATP-C130/ATP-C70) | 05/02/2025 |
| K191000 | Bardy Diagnostics, Inc | Carnation Ambulatory Monitor | 05/16/2019 |
| K191471 | Bardy Diagnostics, Inc | Carnation Ambulatory Monitor | 08/30/2019 |
| K192556 | Bardy Diagnostics, Inc | Carnation Ambulatory Monitor | 10/17/2019 |
| K200870 | Bardy Diagnostics, Inc | Carnation Ambulatory Monitor | 05/01/2020 |
| K143067 | BARDY DIAGNOSTICS, INC. | Carnation Ambulatory Monitor | 12/22/2014 |
| K233110 | Bardy Diagnostics, Inc. | Carnation Ambulatory Monitor | 11/22/2023 |
| K210036 | Bardy Diagnostics, Inc. | Carnation Ambulatory Monitor (CAM) | 02/05/2021 |
| K201040 | Biotricity | Bioflux Software II | 07/29/2020 |
| K162571 | Biotricity Inc. | Bioflux Software | 10/13/2016 |
| K171410 | Braemar Manufacturing, LLC | ePatch | 01/04/2018 |
| K982448 | CAPINTEC, INC. | CARDIOLIGHT | 06/11/1999 |
| K020825 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | KING OF HEARTS EXPRESS + AF MONITOR | 04/05/2002 |
| K111745 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER | 08/01/2011 |
| K130288 | CARDIAC INSIGHT, INC. | STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE | 05/29/2013 |
| K142468 | CARDIAC INSIGHT, INC. | Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System | 07/11/2015 |
| K162503 | Cardiac Insight, Inc. | Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software | 03/24/2017 |
| K113176 | CARDIAC SCIENCE CORPORATION | MYSENSE HEART | 12/21/2011 |
| K022297 | CARDIOCOMM SOLUTIONS, INC. | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) | 09/27/2002 |
| K013354 | CARDIOCOMM SOLUTIONS, INC. | GLOBALCARDIO | 01/31/2002 |
| K111320 | CARDIOCOMM SOLUTIONS, INC. | GLOBALCARDIO | 10/07/2011 |
| K033037 | CARDIOCOMM SOLUTIONS, INC. | MODIFICATION TO GLOBALCARDIO | 10/31/2003 |
| K963174 | DEL MAR AVIONICS | HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) | 03/13/1997 |
| K990027 | DEL MAR AVIONICS | OMNICORDER, MODEL 464 | 02/09/1999 |
| K970298 | DIAGNOSTIC MONITORING | DM-400 HOLTER ECG CASSETTE RECORDER | 08/20/1997 |
| K062007 | DIAGNOSTIC MONITORING SOFTWARE | DMS 300-7 | 08/16/2006 |
| K163535 | DMS-SERVICE LLC | my Patch sl | 02/22/2017 |
| K131190 | DMS-SERVICE LLC | MYPATCH | 10/29/2013 |
| K160704 | DMS-SERVICE LLC | myPatch-s | 07/15/2016 |
| K230184 | Edan Instruments, Inc. | Holter ECG and ABP System | 09/25/2023 |
| K971670 | GALIX BIOMEDICAL INSTRUMENTATION, INC. | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER | 01/29/1998 |
| K202456 | Global Instrumentation LLC | M5 Recorder | 12/29/2020 |
| K982384 | HARLEY STREET SOFTWARE LTD. | MERCATOR | 01/27/1999 |
| K974420 | HEWLETT-PACKARD CO. | M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION | 02/19/1998 |
| K223049 | Icentia Inc. | CardioSTAT« ECG Test Solution | 03/22/2023 |
| K202359 | iRhythm Technologies, Inc. | Zio Monitor | 05/21/2021 |
| K113862 | IRHYTHM TECHNOLOGIES, INC. | ZIO PATCH | 02/06/2012 |
| K121319 | IRHYTHM TECHNOLOGIES, INC. | ZIO PATCH | 07/18/2012 |
| K090363 | IRHYTHM TECHNOLOGIES, INC. | ZIO PATCH, MODEL Z100 | 05/08/2009 |
| K143513 | iRhythm Technologies, Inc. | ZIO SR ECG Monitoring Service | 06/19/2015 |
| K101022 | KARMELSONIX | PULMOTRACK 5050 WHOLTER, MODEL 5050 | 07/09/2010 |
| K203168 | LifeLens Technologies, Inc. | LifeLens Wireless ECG Monitor | 07/20/2021 |
| K944180 | MEMTEC CORP. | MODEL 700 | 03/07/1997 |
| K232670 | Mezoo Co., Ltd. | HiCardi+ H100 | 09/20/2024 |
| K050896 | MORTARA INSTRUMENT, INC. | H12+ HOLTER RECORDER | 08/24/2005 |
| K004007 | NORTHEAST MONITORING, INC. | DR180+OXY | 01/25/2001 |
| K960925 | NORTHEAST MONITORING, INC. | NORTHEAST MONITORING DR180 | 07/31/1996 |
| K970902 | OXFORD INSTRUMENTS MEDICAL SYSTEMS | MEDILOG FD4 | 05/05/1997 |
| K171936 | Peerbridge Health INc. | Peerbridge Cor(TM) System | 09/27/2017 |
| K032103 | PHILIPS MEDICAL SYSTEMS | PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A | 07/22/2003 |
| K201644 | Qardio Inc. | QardioCore | 02/28/2021 |
| K210179 | Quanta Computer Inc. | QOCA Portable ECG Monitoring Device | 08/02/2022 |
| K001025 | REYNOLDS MEDICAL LTD. | LIFECARD CF COMPACT RECORDER | 04/19/2000 |
| K022540 | ROZINN ELECTRONICS, INC. | CARDIO ID+(RZ153+) | 10/24/2002 |
| K973735 | SCHILLER AMERICA, INC. | MICROVIT MT-100 | 08/25/1998 |
| K073152 | SHENZHEN CREATIVE INDUSTRY CO., LTD | PC-180 / PRINCE 180 EASY ECG MONITOR | 01/10/2008 |
| K173461 | Smart Solutions Technologies SL | ECG recorder and Arrhythmia Detector | 08/03/2018 |
| K231104 | SOMNOmedics GmbH | ABPMpro | 11/27/2023 |
| K201077 | Strados Labs | Strados Remote Electronic Stethoscope Platform (RESP) | 12/20/2020 |
| K220893 | Strados Labs, Inc. | Strados Remote Electronic Stethoscope Platform (RESP) | 04/27/2022 |
| K070818 | TOM MEDICAL ENTWICKLUNGS GMBH | MEDILOGAR4, MEDILOGAR12 | 04/06/2007 |
| K092785 | VASOMEDICAL, INC. | COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 | 04/02/2010 |
| K083820 | VASOMEDICAL, INC. | VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C | 04/01/2009 |
| K111180 | VASOMEDICAL, INC. | VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY | 06/28/2011 |
| K111096 | VASOMEDICAL, INC. | VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY | 06/24/2011 |
| K091505 | VIASYS HEALTHCARE GMBH | COR12+ | 06/10/2009 |
| K110525 | VITALOGRAPH(IRELAND) LTD. | VITALOGRAPH MODEL 7100 - VITALOJAK | 11/23/2011 |
| K214073 | WearLinq, Inc. | eWave Monitor | 10/20/2022 |
| K233906 | Wellysis Corp. | S-Patch (S-Patch ExL) | 02/16/2024 |
| K231289 | Wellysis Corp. | S-Patch Ex Wearable ECG Patch | 08/30/2023 |
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