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510(k) K170628

BioMonitor 2-AF, BioMonitor 2-S by Biotronik, Inc. — Product Code MXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2017
Date Received
March 2, 2017
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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  • K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312) (August 19, 2023)
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