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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 K243650
Device Name Zio® monitor (DFG0001)
Applicant
iRhythm Technologies, Inc.
699 8th St.
Suite 600
San Francisco,  CA  94103
Applicant Contact Kiran Sorathia
Correspondent
iRhythm Technologies, Inc.
699 8th St.
Suite 600
San Francisco,  CA  94103
Correspondent Contact Kiran Sorathia
Regulation Number870.2800
Classification Product Code
DSH  
Date Received11/26/2024
Decision Date 08/15/2025
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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