DSH — Recorder, Magnetic Tape, Medical Class II
FDA Device Classification
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 |
|---|
| 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 |
| K201644 | qardio | QardioCore | February 28, 2021 |
| K210036 | bardy diagnostics | Carnation Ambulatory Monitor (CAM) | February 5, 2021 |