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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 K143513
FOIA Releasable 510(k) K143513
Device Name ZIO SR ECG Monitoring Service
Applicant
iRhythm Technologies, Inc.
650 Townsend St., Suite 380
San Francisco,  CA  94103
Applicant Contact Rich Laguna
Correspondent
iRhythm Technologies, Inc.
650 Townsend St., Suite 380
San Francisco,  CA  94103
Correspondent Contact Rich Laguna
Regulation Number870.2800
Classification Product Code
DSH  
Date Received12/11/2014
Decision Date 06/19/2015
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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