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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 K233562
Device Name LINQ II Insertable Cardiac Monitor
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 Received11/06/2023
Decision Date 12/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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