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510(k) K240693

LINQ II™ Insertable Cardiac Monitor (ICM) by Medtronic, Inc. — Product Code MXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2024
Date Received
March 13, 2024
Clearance Type
Special
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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