Product code DSH
- Device name
- Recorder, Magnetic Tape, Medical
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2800
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252389 | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | Smwmed, Inc. | 2026-04-23 |
| K253293 | VitaloJAK Clinic (Model 7100) | Vitalograph , Ltd. | 2025-12-03 |
| K243650 | Zio® monitor (DFG0001) | iRhythm Technologies, Inc. | 2025-08-15 |
| K243603 | AeviceMD | Aevice Health Pte. , Ltd. | 2025-05-05 |
| K242583 | AT-Patch (ATP-C130/ATP-C70) | Atsens Co., Ltd. | 2025-05-02 |
| K232670 | HiCardi+ H100 | MEZOO Co., Ltd. | 2024-09-20 |
| K233906 | S-Patch (S-Patch ExL) | Wellysis Corp. | 2024-02-16 |
| K231104 | ABPMpro | Somnomedics GmbH | 2023-11-27 |
| K233110 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2023-11-22 |
| K230184 | Holter ECG and ABP System | Edan Instruments, Inc. | 2023-09-25 |
| K231289 | S-Patch Ex Wearable ECG Patch | Wellysis Corp. | 2023-08-30 |
| K223382 | AeviceMD | Aevice Health Pte. , Ltd. | 2023-07-07 |
| K223049 | CardioSTAT® ECG Test Solution | Icentia, Inc. | 2023-03-22 |
| K214073 | eWave Monitor | Wearlinq, Inc. | 2022-10-20 |
| K203638 | AT-Patch ECG Analysis System | Atsens Co., Ltd. | 2022-10-12 |
| K210179 | QOCA Portable ECG Monitoring Device | Quanta Computer, Inc. | 2022-08-02 |
| K220893 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs, Inc. | 2022-04-27 |
| K203168 | LifeLens Wireless ECG Monitor | LifeLens Technologies, Inc. | 2021-07-20 |
| K202359 | Zio Monitor | iRhythm Technologies, Inc. | 2021-05-21 |
| K201644 | QardioCore | Qardio, Inc. | 2021-02-28 |
| K210036 | Carnation Ambulatory Monitor (CAM) | Bardy Diagnostics, Inc. | 2021-02-05 |
| K202456 | M5 Recorder | Global Instrumentation, LLC | 2020-12-29 |
| K201077 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs | 2020-12-20 |
| K201040 | Bioflux Software II | Biotricity | 2020-07-29 |
| K200870 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2020-05-01 |
| K192556 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2019-10-17 |
| K191471 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2019-08-30 |
| K191000 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | 2019-05-16 |
| K173461 | ECG recorder and Arrhythmia Detector | Smart Solutions Technologies SL | 2018-08-03 |
| K172862 | Portable ECG Monitor (ECG3) | Andon Health Co, Ltd. | 2018-07-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08883000007413 | AeviceMD | AEVICE HEALTH PTE. LTD. | 2026-05-18 |
| K00010 | eWave 6-Lead EKG | Wearlinq, Inc. | 2026-04-02 |
| 08800069700260 | AT-Patch | ATsens Co., Ltd. | 2025-11-05 |
| 08800069700277 | AT-Patch | ATsens Co., Ltd. | 2025-11-05 |
| 08800069700178 | AT-Patch | ATsens Co., Ltd. | 2022-12-23 |
| 15099169715117 | VitaloJAK | VITALOGRAPH (IRELAND) LIMITED | 2021-06-18 |
| 20851398007010 | Carnation Ambulatory Monitor | BARDY DIAGNOSTICS, INC. | 2019-12-20 |
| 10841522103834 | UltraviewSL | SPACELABS HEALTHCARE (WASHINGTON), INC | 2019-01-14 |
| 15099169715100 | VitaloJAK | VITALOGRAPH (IRELAND) LIMITED | 2018-05-17 |
| 15099169710235 | VitaloJAK | VITALOGRAPH (IRELAND) LIMITED | 2018-05-17 |
| 15099169710020 | VitaloJAK | VITALOGRAPH (IRELAND) LIMITED | 2018-05-14 |
| 10841522122644 | SPACELABS HEALTHCARE | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-11-22 |
| 10841522123313 | Lifecard CF | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-11-14 |
| 10841522123146 | SPACELABS HEALTHCARE | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-09-07 |
| 10841522111846 | SPACELABS HEALTHCARE | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-08-07 |
| 10841522111884 | SPACELABS HEALTHCARE | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-08-07 |
| 10841522111914 | SPACELABS HEALTHCARE | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-08-07 |
| 10841522123054 | SPACELABS HEALTHCARE | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-08-07 |
| 10841522123061 | SPACELABS HEALTHCARE | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-08-07 |
| 10857553006129 | Cardea SOLO | CARDIAC INSIGHT, INC. | 2017-07-31 |
| 10857553006112 | Cardea SOLO | CARDIAC INSIGHT, INC. | 2017-07-31 |
| 10841522103810 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-04 |
| 10841522103827 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-04 |
| 10841522111822 | SPACELABS HEALTHCARE | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-04 |
| 10841522111815 | SPACELABS HEALTHCARE | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-04 |
| 10841522111792 | SPACELABS HEALTHCARE | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-04 |
| 10841522111785 | SPACELABS HEALTHCARE | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-04 |
| 10841522111761 | SPACELABS HEALTHCARE | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-04 |
| 10841522111754 | SPACELABS HEALTHCARE | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-04 |
| 10841522111730 | SPACELABS HEALTHCARE | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-04 |