DSH
- Product code
- DSH
- Device name
- Recorder, Magnetic Tape, Medical
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2800
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 11
- Summaries archived here
- 9 (direct download)
- 510(k) clearances (all years, FDA)
- 195 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (11)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260157 | 2026-07-09 | LifeLens Technologies, Inc. | LifeLens Physiological Monitor | |
| K252389 | 2026-04-23 | Smwmed, Inc. | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-… | |
| K253293 | 2025-12-03 | Vitalograph , Ltd. | VitaloJAK Clinic (Model 7100) | |
| K243650 | 2025-08-15 | iRhythm Technologies, Inc. | Zio® monitor (DFG0001) | |
| K243603 | 2025-05-05 | Aevice Health Pte. , Ltd. | AeviceMD | |
| K242583 | 2025-05-02 | Atsens Co., Ltd. | AT-Patch (ATP-C130/ATP-C70) | |
| K232670 | 2024-09-20 | MEZOO Co., Ltd. | HiCardi+ H100 | |
| K233906 | 2024-02-16 | Wellysis Corp. | S-Patch (S-Patch ExL) | FDA |
| K231104 | 2023-11-27 | Somnomedics GmbH | ABPMpro | |
| K233110 | 2023-11-22 | Bardy Diagnostics, Inc. | Carnation Ambulatory Monitor | — |
| K230184 | 2023-09-25 | Edan Instruments, Inc. | Holter ECG and ABP System |
Official FDA classification page: DSH
Classification and pathway per current FDA publications. Data from openFDA (CC0).