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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 K113862
Device Name ZIO PATCH
Applicant
iRhythm Technologies, Inc.
650 Townsend St., Suite 380
San Francisco,  CA  94103
Applicant Contact MICHAEL RIGHTER
Correspondent
iRhythm Technologies, Inc.
650 Townsend St., Suite 380
San Francisco,  CA  94103
Correspondent Contact MICHAEL RIGHTER
Regulation Number870.2800
Classification Product Code
DSH  
Date Received12/30/2011
Decision Date 02/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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