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iRhythm Technologies, Inc.

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K252859 ZEUS Platform (FG0501US)DQK2026-05-29 View
510(k) K243650 Zio® monitor (DFG0001)DSH2025-08-15 View
510(k) K240177 Zio AT® device (A100A1001)DSI2024-10-30 View
510(k) K240029 Zio AT® device (A100A1001)QYX2024-10-21 View
510(k) K222389 ZEUS SystemDQK2023-02-15 View
510(k) K213409 ZEUS System (Zio Watch)DQK2022-07-19 View
510(k) K202527 Zio ECG Utilization Software (ZEUS) SystemDQK2021-05-21 View
510(k) K202359 Zio MonitorDSH2021-05-21 View
510(k) K190593 Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemDQK2019-08-23 View
510(k) K181502 Zio AT ECG Monitoring System, ZEUS SystemDQK2018-08-29 View
510(k) K163512 Zio AT ECG Monitoring SystemQYX2017-06-02 View
510(k) K121319 ZIO PATCHDSH2012-07-18 View
510(k) K113862 ZIO PATCHDSH2012-02-06 View
510(k) K091075 ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEMDQK2009-07-21 View
510(k) K090363 ZIO PATCH, MODEL Z100DSH2009-05-08 View
510(k) K081471 ECARD AND CCARDDXH2008-06-24 View
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