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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 K221962
Device Name LINQ II Insertable Cardiac Monitor
Applicant
Medtronic, Inc.
8200 Coral Sea Street NE
MS-MVS11
Mounds View,  MN  55112
Applicant Contact Dianna L. Johannson
Correspondent
Medtronic, Inc.
8200 Coral Sea Street NE
MS-MVS11
Mounds View,  MN  55112
Correspondent Contact Dianna L. Johannson
Regulation Number870.1025
Classification Product Code
MXD  
Date Received07/05/2022
Decision Date 08/25/2022
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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