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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 K210484
Device Name LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
Applicant
Medtronic, Inc.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Applicant Contact Dianna L Johannson
Correspondent
Medtronic, Inc.
8200 Coral Sea Street NE
Mounds View,  MN  55112
Correspondent Contact Dianna L Johannson
Regulation Number870.1025
Classification Product Code
MXD  
Date Received02/19/2021
Decision Date 06/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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