iRhythm Technologies, Inc.
FDA 510(k) & PMA Approved Devices — 11 products
Total Devices11
Categories4
Latest FDA decision2026-05-29
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K252859 | ZEUS Platform (FG0501US) | DQK | 2026-05-29 | View |
| 510(k) | K243650 | Zio® monitor (DFG0001) | DSH | 2025-08-15 | View |
| 510(k) | K240177 | Zio AT® device (A100A1001) | DSI | 2024-10-30 | View |
| 510(k) | K240029 | Zio AT® device (A100A1001) | QYX | 2024-10-21 | View |
| 510(k) | K222389 | ZEUS System | DQK | 2023-02-15 | View |
| 510(k) | K213409 | ZEUS System (Zio Watch) | DQK | 2022-07-19 | View |
| 510(k) | K202527 | Zio ECG Utilization Software (ZEUS) System | DQK | 2021-05-21 | View |
| 510(k) | K202359 | Zio Monitor | DSH | 2021-05-21 | View |
| 510(k) | K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | DQK | 2019-08-23 | View |
| 510(k) | K181502 | Zio AT ECG Monitoring System, ZEUS System | DQK | 2018-08-29 | View |
| 510(k) | K163512 | Zio AT ECG Monitoring System | QYX | 2017-06-02 | View |
No matching devices.