FDA 510(k), K201989, B4C System

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

• Total Pages: 4,821
• Fully Redacted Pages: 920
• Content Pages: 3,901 (Total pages minus fully redacted pages)