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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 K223630
Device Name Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
Applicant
Medtronic, Inc.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Applicant Contact Kerry Luyster
Correspondent
Medtronic, Inc.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Correspondent Contact Kerry Luyster
Regulation Number870.1025
Classification Product Code
MXD  
Date Received12/05/2022
Decision Date 04/05/2023
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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