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510(k) K210608

LUX-Dx Insertable Cardiac Monitor by Boston Scientific Corporation — Product Code MXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2021
Date Received
March 1, 2021
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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