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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 K162855
Device Name Reveal LINQ
Applicant
Medtronic, Inc.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Applicant Contact Syed Sumran Mohiuddin
Correspondent
Medtronic, Inc.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Correspondent Contact Syed Sumran Mohiuddin
Regulation Number870.1025
Classification Product Code
MXD  
Date Received10/12/2016
Decision Date 02/23/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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