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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 K213409
Device Name ZEUS System (Zio Watch)
Applicant
iRhythm Technologies, Inc.
699 8th Street, Suite 600
San Francisco,  CA  94103
Applicant Contact Vishal Kanani
Correspondent
iRhythm Technologies, Inc.
699 8th Street, Suite 600
San Francisco,  CA  94103
Correspondent Contact Vishal Kanani
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DXH  
Date Received10/19/2021
Decision Date 07/19/2022
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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