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510(k) K221962

LINQ II Insertable Cardiac Monitor by Medtronic, Inc. — Product Code MXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2022
Date Received
July 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

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