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FDA 510(k), K200444, Biomonitor III, Biomonitor IIIm
FDA 510(k), K200444, Biomonitor III, Biomonitor IIIm
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510(K) Number: K200444
Device Name: Biomonitor III, Biomonitor IIIm
Manufacturer: Jon Brumbaugh
Device Classification Name: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Regulation Number: MXD
Classification Product Code: 02/24/2020
Date Received: 04/23/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Biomonitor III, Biomonitor IIIm
Manufacturer: Jon Brumbaugh
Device Classification Name: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Regulation Number: MXD
Classification Product Code: 02/24/2020
Date Received: 04/23/2020
Decision Date: Substantially Equivalent (SESE)
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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