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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
Model Z100
Device Name ZIO PATCH
Original Applicant
IRHYTHM TECHNOLOGIES, INC.
650 townsend street
suite 380
san francisco,  CA  94103
Original Contact michael righter
Regulation Number870.2800
Classification Product Code
DSH  
Date Received12/30/2011
Decision Date 02/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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