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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 K121319
Model N100
Device Name ZIO PATCH
Original Applicant
650 townsend street
suite 380
san francisco,  CA  94103
Original Contact michael righter
Regulation Number870.2800
Classification Product Code
Date Received05/02/2012
Decision Date 07/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No