Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2800](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2800) → DSH — Recorder, Magnetic Tape, Medical # DSH · Recorder, Magnetic Tape, Medical _Cardiovascular · 21 CFR 870.2800 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH ## Overview - **Product Code:** DSH - **Device Name:** Recorder, Magnetic Tape, Medical - **Regulation:** [21 CFR 870.2800](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2800) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 194) Showing 20 most recent of 194 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252389](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K252389.md) | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | Smwmed, Inc. | Apr 23, 2026 | SESE | | [K253293](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K253293.md) | VitaloJAK Clinic (Model 7100) | Vitalograph , Ltd. | Dec 3, 2025 | SESE | | [K243650](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K243650.md) | Zio® monitor (DFG0001) | iRhythm Technologies, Inc. | Aug 15, 2025 | SESE | | [K243603](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K243603.md) | AeviceMD | Aevice Health Pte. , Ltd. | May 5, 2025 | SESE | | [K242583](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K242583.md) | AT-Patch (ATP-C130/ATP-C70) | Atsens Co., Ltd. | May 2, 2025 | SESE | | [K232670](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K232670.md) | HiCardi+ H100 | MEZOO Co., Ltd. | Sep 20, 2024 | SESE | | [K233906](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K233906.md) | S-Patch (S-Patch ExL) | Wellysis Corp. | Feb 16, 2024 | SESE | | [K231104](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K231104.md) | ABPMpro | Somnomedics GmbH | Nov 27, 2023 | SESE | | [K233110](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K233110.md) | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | Nov 22, 2023 | SESE | | [K230184](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K230184.md) | Holter ECG and ABP System | Edan Instruments, Inc. | Sep 25, 2023 | SESE | | [K231289](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K231289.md) | S-Patch Ex Wearable ECG Patch | Wellysis Corp. | Aug 30, 2023 | SESE | | [K223382](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K223382.md) | AeviceMD | Aevice Health Pte. , Ltd. | Jul 7, 2023 | SESE | | [K223049](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K223049.md) | CardioSTAT® ECG Test Solution | Icentia, Inc. | Mar 22, 2023 | SESE | | [K214073](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K214073.md) | eWave Monitor | Wearlinq, Inc. | Oct 20, 2022 | SESE | | [K203638](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K203638.md) | AT-Patch ECG Analysis System | Atsens Co., Ltd. | Oct 12, 2022 | SESE | | [K210179](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K210179.md) | QOCA Portable ECG Monitoring Device | Quanta Computer, Inc. | Aug 2, 2022 | SESE | | [K220893](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K220893.md) | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs, Inc. | Apr 27, 2022 | SESE | | [K203168](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K203168.md) | LifeLens Wireless ECG Monitor | LifeLens Technologies, Inc. | Jul 20, 2021 | SESE | | [K202359](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K202359.md) | Zio Monitor | iRhythm Technologies, Inc. | May 21, 2021 | SESE | | [K201644](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH/K201644.md) | QardioCore | Qardio, Inc. | Feb 28, 2021 | SESE | ## Top Applicants - Del Mar Avionics — 15 clearances - Bardy Diagnostics, Inc. — 7 clearances - Oxford Medilog, Inc. — 6 clearances - iRhythm Technologies, Inc. — 6 clearances - Cardiocomm Solutions, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com