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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K240177
Device Name Zio AT® device (A100A1001)
Applicant
iRhythm Technologies, Inc.
699 8th St.
Suite 600
San Francisco,  CA  94103
Applicant Contact Soyini Hamit
Correspondent
iRhythm Technologies, Inc.
699 8th St.
Suite 600
San Francisco,  CA  94103
Correspondent Contact Soyini Hamit
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Codes
DSH   DXH   QYX  
Date Received01/23/2024
Decision Date 10/30/2024
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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