DSH — Recorder, Magnetic Tape, Medical Class II
FDA product code DSH covers "Recorder, Magnetic Tape, Medical", a Class II medical device regulated under 21 CFR 870.2800. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DSH
- Device Class
- Class II
- Regulation Number
- 870.2800
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260157 | lifelens technologies | LifeLens Physiological Monitor | July 9, 2026 |
| K252389 | smwmed | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | April 23, 2026 |
| K253293 | vitalograph | VitaloJAK Clinic (Model 7100) | December 3, 2025 |
| K243650 | irhythm technologies | Zio® monitor (DFG0001) | August 15, 2025 |
| K243603 | aevice health pte. | AeviceMD | May 5, 2025 |
| K242583 | atsens co | AT-Patch (ATP-C130/ATP-C70) | May 2, 2025 |
| K232670 | mezoo co | HiCardi+ H100 | September 20, 2024 |
| K233906 | wellysis | S-Patch (S-Patch ExL) | February 16, 2024 |
| K231104 | somnomedics | ABPMpro | November 27, 2023 |
| K233110 | bardy diagnostics | Carnation Ambulatory Monitor | November 22, 2023 |
| K230184 | edan instruments | Holter ECG and ABP System | September 25, 2023 |
| K231289 | wellysis | S-Patch Ex Wearable ECG Patch | August 30, 2023 |
| K223382 | aevice health pte. | AeviceMD | July 7, 2023 |
| K223049 | icentia | CardioSTAT® ECG Test Solution | March 22, 2023 |
| K214073 | wearlinq | eWave Monitor | October 20, 2022 |
| K203638 | atsens co | AT-Patch ECG Analysis System | October 12, 2022 |
| K210179 | quanta computer | QOCA Portable ECG Monitoring Device | August 2, 2022 |
| K220893 | strados labs | Strados Remote Electronic Stethoscope Platform (RESP) | April 27, 2022 |
| K203168 | lifelens technologies | LifeLens Wireless ECG Monitor | July 20, 2021 |
| K202359 | irhythm technologies | Zio Monitor | May 21, 2021 |