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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 K222389
Device Name ZEUS System
Applicant
iRhythm Technologies, Inc.
699 8th Street
San Francisco,  CA  94103
Applicant Contact Vishal Kanani
Correspondent
iRhythm Technologies, Inc.
699 8th Street
San Francisco,  CA  94103
Correspondent Contact Vishal Kanani
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DSI   DXH  
Date Received08/08/2022
Decision Date 02/15/2023
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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