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iRhythm Technologies, Inc.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories4
Latest Approval2025-08-15
TypeNumberDevice NameCodeDate
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