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FDA 510(k), K201865, Biomonitor III, Biomonitor IIIm
FDA 510(k), K201865, Biomonitor III, Biomonitor IIIm
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510(K) Number: K201865
Device Name: Biomonitor III, Biomonitor IIIm
Manufacturer: Biotronik, Inc.
Device Classification Name: recorder, event, implantable cardiac, (with arrhythmia detection)
Regulation Number: 870.1025
Classification Product Code: MXD
Date Received: 07/06/2020
Decision Date: 12/08/2020
Regulation Medical Specialty: Cardiovascular
Device Name: Biomonitor III, Biomonitor IIIm
Manufacturer: Biotronik, Inc.
Device Classification Name: recorder, event, implantable cardiac, (with arrhythmia detection)
Regulation Number: 870.1025
Classification Product Code: MXD
Date Received: 07/06/2020
Decision Date: 12/08/2020
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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