Zio Monitor

Recorder, Magnetic Tape, Medical

IRhythm Technologies, Inc.

The following data is part of a premarket notification filed by Irhythm Technologies, Inc. with the FDA for Zio Monitor.

Pre-market Notification Details

Device IDK202359
510k NumberK202359
Device Name:Zio Monitor
ClassificationRecorder, Magnetic Tape, Medical
Applicant iRhythm Technologies, Inc. 699 8th Street San Francisco,  CA  94103
ContactRich Laguna
CorrespondentRey Jacinto
iRhythm Technologies, Inc. 699 8th Street San Francisco,  CA  94103
Product CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-19
Decision Date2021-05-21

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