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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 K200795
Device Name LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit
Applicant
Medtronic, Inc.
8200 Coral Sea Street NE
mounds view,  MN  55112
Applicant Contact eric kalmes
Correspondent
Medtronic, Inc.
8200 Coral Sea Street NE
mounds view,  MN  55112
Correspondent Contact eric kalmes
Regulation Number870.1025
Classification Product Code
MXD  
Date Received03/26/2020
Decision Date 07/03/2020
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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