Panels › Cardiovascular › Product code DSH · Class 2
Recorder, Magnetic Tape, Medical
Regulation 870.2800
3510(k)s in 12 months (195 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DSH
| Company | 510(k)s | Recalls |
|---|---|---|
| Del Mar Avionics | 15 | 0 |
| Bardy Diagnostics, Inc. | 7 | 0 |
| iRhythm Technologies, Inc. | 6 | 0 |
| Oxford Medilog, Inc. | 6 | 0 |
| Cardiocomm Solutions, Inc. | 4 | 0 |
| Cardionostics, Inc. | 4 | 0 |
| Reynolds Medical , Ltd. | 4 | 0 |
| Vasomedical, Inc. | 4 | 0 |
| Aequitron Medical, Inc. | 3 | 0 |
| American Edwards Laboratories | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 9, 2026 | K260157 | LifeLens Physiological Monitor LifeLens Technologies, Inc. | DSH |
| Apr 23, 2026 | K252389 | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) Smwmed, Inc. | DSH |
| Dec 3, 2025 | K253293 | VitaloJAK Clinic (Model 7100) Vitalograph , Ltd., IE | DSH |
| Aug 15, 2025 | K243650 | Zio® monitor (DFG0001) iRhythm Technologies, Inc. | DSH |
| May 5, 2025 | K243603 | AeviceMD Aevice Health Pte. , Ltd., SG | DSH |
| May 2, 2025 | K242583 | AT-Patch (ATP-C130/ATP-C70) Atsens Co., Ltd., KR | DSH |
| Sep 20, 2024 | K232670 | HiCardi+ H100 MEZOO Co., Ltd., KR | DSH |
| Feb 16, 2024 | K233906 | S-Patch (S-Patch ExL) Wellysis Corp., KR | DSH |
| Nov 27, 2023 | K231104 | ABPMpro Somnomedics GmbH, DE | DSH |
| Nov 22, 2023 | K233110 | Carnation Ambulatory Monitor Bardy Diagnostics, Inc. | DSH |
| Sep 25, 2023 | K230184 | Holter ECG and ABP System Edan Instruments, Inc., CN | DSH |
| Aug 30, 2023 | K231289 | S-Patch Ex Wearable ECG Patch Wellysis Corp., KR | DSH |
| Jul 7, 2023 | K223382 | AeviceMD Aevice Health Pte. , Ltd., SG | DSH |
| Mar 22, 2023 | K223049 | CardioSTAT® ECG Test Solution Icentia, Inc., CA | DSH |
| Oct 20, 2022 | K214073 | eWave Monitor Wearlinq, Inc. | DSH |
| Oct 12, 2022 | K203638 | AT-Patch ECG Analysis System Atsens Co., Ltd., KR | DSH |
| Aug 2, 2022 | K210179 | QOCA Portable ECG Monitoring Device Quanta Computer, Inc., TW | DSH |
| Apr 27, 2022 | K220893 | Strados Remote Electronic Stethoscope Platform (RESP) Strados Labs, Inc. | DSH |
| Jul 20, 2021 | K203168 | LifeLens Wireless ECG Monitor LifeLens Technologies, Inc. | DSH |
| May 21, 2021 | K202359 | Zio Monitor iRhythm Technologies, Inc. | DSH |
| Feb 28, 2021 | K201644 | QardioCore Qardio, Inc. | DSH |
| Feb 5, 2021 | K210036 | Carnation Ambulatory Monitor (CAM) Bardy Diagnostics, Inc. | DSH |
| Dec 29, 2020 | K202456 | M5 Recorder Global Instrumentation, LLC | DSH |
| Dec 20, 2020 | K201077 | Strados Remote Electronic Stethoscope Platform (RESP) Strados Labs | DSH |
| Jul 29, 2020 | K201040 | Bioflux Software II Biotricity | DSH |
| May 1, 2020 | K200870 | Carnation Ambulatory Monitor Bardy Diagnostics, Inc. | DSH |
| Oct 17, 2019 | K192556 | Carnation Ambulatory Monitor Bardy Diagnostics, Inc. | DSH |
| Aug 30, 2019 | K191471 | Carnation Ambulatory Monitor Bardy Diagnostics, Inc. | DSH |
| May 16, 2019 | K191000 | Carnation Ambulatory Monitor Bardy Diagnostics, Inc. | DSH |
| Aug 3, 2018 | K173461 | ECG recorder and Arrhythmia Detector Smart Solutions Technologies SL, ES | DSH |
| Jul 24, 2018 | K172862 | Portable ECG Monitor (ECG3) Andon Health Co, Ltd., CN | DSH |
| Jan 4, 2018 | K171410 | ePatch Braemar Manufacturing, LLC | DSH |
| Sep 27, 2017 | K171936 | Peerbridge Cor(TM) System Peerbridge Health, Inc. | DSH |
| Mar 24, 2017 | K162503 | Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software Cardiac Insight, Inc. | DSH |
| Feb 22, 2017 | K163535 | my Patch sl Dms-Service, LLC | DSH |
| Oct 13, 2016 | K162571 | Bioflux Software Biotricity, Inc., CA | DSH |
| Jul 15, 2016 | K160704 | myPatch-s Dms-Service, LLC | DSH |
| Jul 11, 2015 | K142468 | Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System Cardiac Insight, Inc. | DSH |
| Jun 19, 2015 | K143513 | ZIO SR ECG Monitoring Service iRhythm Technologies, Inc. | DSH |
| Dec 22, 2014 | K143067 | Carnation Ambulatory Monitor Bardy Diagnostics, Inc. | DSH |
| Oct 29, 2013 | K131190 | MYPATCH Dms-Service, LLC | DSH |
| May 29, 2013 | K130288 | STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE Cardiac Insight, Inc. | DSH |
| Jul 18, 2012 | K121319 | ZIO PATCH iRhythm Technologies, Inc. | DSH |
| Feb 6, 2012 | K113862 | ZIO PATCH iRhythm Technologies, Inc. | DSH |
| Dec 21, 2011 | K113176 | MYSENSE HEART Cardiac Science Corporation | DSH |
| Nov 23, 2011 | K110525 | VITALOGRAPH MODEL 7100 - VITALOJAK Vitalograph (Ireland) , Ltd., IE | DSH |
| Oct 7, 2011 | K111320 | GLOBALCARDIO Cardiocomm Solutions, Inc. | DSH |
| Aug 1, 2011 | K111745 | KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER Card Guard Scientific Survival , Ltd. | DSH |
| Jun 28, 2011 | K111180 | VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY Vasomedical, Inc. | DSH |
| Jun 24, 2011 | K111096 | VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY Vasomedical, Inc. | DSH |
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