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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K202527
Device Name Zio ECG Utilization Software (ZEUS) System
Applicant
iRhythm Technologies, Inc.
699 8th Street
San Francisco,  CA  94103
Applicant Contact Gabrielle Logan
Correspondent
iRhythm Technologies, Inc.
699 8th Street
San Francisco,  CA  94103
Correspondent Contact Rey Jacinto
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DSI   DXH  
Date Received09/01/2020
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
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