DSH · Recorder, Magnetic Tape, Medical
Cardiovascular · 21 CFR 870.2800 · Class 2
Overview
| Product Code | DSH |
|---|---|
| Device Name | Recorder, Magnetic Tape, Medical |
| Regulation | 21 CFR 870.2800 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | Smwmed, Inc. | Apr 23, 2026 | SESE |
| K253293 | VitaloJAK Clinic (Model 7100) | Vitalograph , Ltd. | Dec 3, 2025 | SESE |
| K243650 | Zio® monitor (DFG0001) | iRhythm Technologies, Inc. | Aug 15, 2025 | SESE |
| K243603 | AeviceMD | Aevice Health Pte. , Ltd. | May 5, 2025 | SESE |
| K242583 | AT-Patch (ATP-C130/ATP-C70) | Atsens Co., Ltd. | May 2, 2025 | SESE |
| K232670 | HiCardi+ H100 | MEZOO Co., Ltd. | Sep 20, 2024 | SESE |
| K233906 | S-Patch (S-Patch ExL) | Wellysis Corp. | Feb 16, 2024 | SESE |
| K231104 | ABPMpro | Somnomedics GmbH | Nov 27, 2023 | SESE |
| K233110 | Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. | Nov 22, 2023 | SESE |
| K230184 | Holter ECG and ABP System | Edan Instruments, Inc. | Sep 25, 2023 | SESE |
| K231289 | S-Patch Ex Wearable ECG Patch | Wellysis Corp. | Aug 30, 2023 | SESE |
| K223382 | AeviceMD | Aevice Health Pte. , Ltd. | Jul 7, 2023 | SESE |
| K223049 | CardioSTAT® ECG Test Solution | Icentia, Inc. | Mar 22, 2023 | SESE |
| K214073 | eWave Monitor | Wearlinq, Inc. | Oct 20, 2022 | SESE |
| K203638 | AT-Patch ECG Analysis System | Atsens Co., Ltd. | Oct 12, 2022 | SESE |
| K210179 | QOCA Portable ECG Monitoring Device | Quanta Computer, Inc. | Aug 2, 2022 | SESE |
| K220893 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs, Inc. | Apr 27, 2022 | SESE |
| K203168 | LifeLens Wireless ECG Monitor | LifeLens Technologies, Inc. | Jul 20, 2021 | SESE |
| K202359 | Zio Monitor | iRhythm Technologies, Inc. | May 21, 2021 | SESE |
| K201644 | 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
