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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, (with arrhythmia detection)
510(k) Number K132649
Device Name REVEAL LINQ INSERTABLE CARDIAC MONITOR
Applicant
MEDTRONIC INC.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Applicant Contact ERIC KALMES
Correspondent
MEDTRONIC INC.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Correspondent Contact ERIC KALMES
Regulation Number870.1025
Classification Product Code
MXD  
Date Received08/26/2013
Decision Date 02/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT00680927
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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