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FDA 510(k), K182073, BcSs-PICNI-2000 Sensor
FDA 510(k), K182073, BcSs-PICNI-2000 Sensor
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510(K) Number: K182073
Device Name: BcSs-PICNI-2000 Sensor
Manufacturer: Arnaldo Betta
Device Classification Name: Device, Monitoring, Intracranial Pressure
Regulation Number: GWM
Classification Product Code: 08/01/2018
Date Received: 10/17/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: BcSs-PICNI-2000 Sensor
Manufacturer: Arnaldo Betta
Device Classification Name: Device, Monitoring, Intracranial Pressure
Regulation Number: GWM
Classification Product Code: 08/01/2018
Date Received: 10/17/2019
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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