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iRhythm Technologies, Inc.

18 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ZEUS Platform (FG0501US) (K252859)iRhythm Technologies, Inc.2026-05-29
Zio® monitor (DFG0001) (K243650)iRhythm Technologies, Inc.2025-08-15
Zio AT® device (A100A1001) (K240177)iRhythm Technologies, Inc.2024-10-30
Zio AT® device (A100A1001) (K240029)iRhythm Technologies, Inc.2024-10-21
ZEUS System (K222389)iRhythm Technologies, Inc.2023-02-15
ZEUS System (Zio Watch) (K213409)iRhythm Technologies, Inc.2022-07-19
Zio ECG Utilization Software (ZEUS) System (K202527)iRhythm Technologies, Inc.2021-05-21
Zio Monitor (K202359)iRhythm Technologies, Inc.2021-05-21
Zio XT ECG Monitoring System, Zio AT ECG Monitoring System (K190593)iRhythm Technologies, Inc.2019-08-23
Zio AT ECG Monitoring System, ZEUS System (K181502)iRhythm Technologies, Inc.2018-08-29
Zio AT ECG Monitoring System (K163512)iRhythm Technologies, Inc.2017-06-02
ZIO SR ECG Monitoring Service (K143513)iRhythm Technologies, Inc.2015-06-19
ZEUS (ZIO ECG Utilization Service) System (K142681)iRhythm Technologies, Inc.2014-11-21
ZIO PATCH (K121319)iRhythm Technologies, Inc.2012-07-18
ZIO PATCH (K113862)iRhythm Technologies, Inc.2012-02-06
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM (K091075)iRhythm Technologies, Inc.2009-07-21
ZIO PATCH, MODEL Z100 (K090363)iRhythm Technologies, Inc.2009-05-08
ECARD AND CCARD (K081471)iRhythm Technologies, Inc.2008-06-24

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Every clearance here is in the API, with alerts when new ones post.