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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name recorder, event, implantable cardiac, (without arrhythmia detection)
510(k) Number K173232
Device Name myMerlin(TM) Mobile Application Model APP1001
Applicant
St. Jude Medical
15900 Valley View Ct.
Sylmar,  CA  91342
Applicant Contact Jennifer Dunham
Correspondent
St. Jude Medical
15900 Valley View Ct.
Sylmar,  CA  91342
Correspondent Contact Jennifer Dunham
Regulation Number870.2800
Classification Product Code
MXC  
Subsequent Product Code
DSI  
Date Received10/04/2017
Decision Date 11/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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