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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K202359
Device Name Zio Monitor
Applicant
iRhythm Technologies, Inc.
699 8th St.
San Francisco,  CA  94103
Applicant Contact Rich Laguna
Correspondent
iRhythm Technologies, Inc.
699 8th St.
San Francisco,  CA  94103
Correspondent Contact Rey Jacinto
Regulation Number870.2800
Classification Product Code
DSH  
Date Received08/19/2020
Decision Date 05/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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