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FDA 510(k), K201989, B4C System
FDA 510(k), K201989, B4C System
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510(K) Number: K201989
Device Name: B4C System
Manufacturer: Arnaldo Betta
Device Classification Name: Device, Monitoring, Intracranial Pressure
Regulation Number: GWM
Classification Product Code: 07/17/2020
Date Received: 10/08/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: B4C System
Manufacturer: Arnaldo Betta
Device Classification Name: Device, Monitoring, Intracranial Pressure
Regulation Number: GWM
Classification Product Code: 07/17/2020
Date Received: 10/08/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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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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