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Informational only. Not affiliated with any government agency. Verify details at the official source.

Devices

iRhythm Technologies, Inc.

6 AI-enabled device listings under this company name on the FDA list. The name is copied as published. It is not a review of the company.

DateSubmissionDevicePanelCode
May 29, 2026K252859ZEUS Platform (FG0501US)CardiovascularDQK
February 15, 2023K222389ZEUS SystemCardiovascularDQK
July 19, 2022K213409ZEUS System (Zio Watch)CardiovascularDQK
May 21, 2021K202527Zio ECG Utilization Software (ZEUS) SystemCardiovascularDQK
August 23, 2019K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemCardiovascularDQK
August 29, 2018K181502Zio AT ECG Monitoring System, ZEUS SystemCardiovascularDQK