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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 K193310
Device Name myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)
Applicant
Abbott (St. Jude Medical)
15900 Valley View Ct.
Sylmar,  CA  91342
Applicant Contact Vanessa Powell
Correspondent
Abbott (St. Jude Medical)
15900 Valley View Ct.
Sylmar,  CA  91342
Correspondent Contact Vanessa Powell
Regulation Number870.2800
Classification Product Code
MXC  
Subsequent Product Code
DSI  
Date Received11/29/2019
Decision Date 03/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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