Zio ECG Utilization Software (ZEUS) System

Computer, Diagnostic, Programmable

IRhythm Technologies, Inc.

The following data is part of a premarket notification filed by Irhythm Technologies, Inc. with the FDA for Zio Ecg Utilization Software (zeus) System.

Pre-market Notification Details

Device IDK202527
510k NumberK202527
Device Name:Zio ECG Utilization Software (ZEUS) System
ClassificationComputer, Diagnostic, Programmable
Applicant iRhythm Technologies, Inc. 699 8th Street San Francisco,  CA  94103
ContactGabrielle Logan
CorrespondentRey Jacinto
iRhythm Technologies, Inc. 699 8th Street San Francisco,  CA  94103
Product CodeDQK  
Subsequent Product CodeDSI
Subsequent Product CodeDXH
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-01
Decision Date2021-05-21

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