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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
Device Name ZIO PATCH
Applicant
IRHYTHM TECHNOLOGIES, INC.
650 TOWNSEND STREET
SUITE 380
SAN FRANCISCO,  CA  94103
Applicant Contact MICHAEL RIGHTER
Correspondent
IRHYTHM TECHNOLOGIES, INC.
650 TOWNSEND STREET
SUITE 380
SAN FRANCISCO,  CA  94103
Correspondent Contact MICHAEL RIGHTER
Regulation Number870.2800
Classification Product Code
DSH  
Date Received05/02/2012
Decision Date 07/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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