Cleared Traditional

B4C System

K201989 · Braincare Desenvolvimento E Inovacao Tecnologica S.A. · Neurology
Oct 2021
Decision
448d
Days
Class 2
Risk

About This 510(k) Submission

K201989 is an FDA 510(k) clearance for the B4C System, a Device, Monitoring, Intracranial Pressure (Class II — Special Controls, product code GWM), submitted by Braincare Desenvolvimento E Inovacao Tecnologica S.A. (S?o Carlos, BR). The FDA issued a Cleared decision on October 8, 2021, 448 days after receiving the submission on July 17, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1620.

Submission Details

510(k) Number K201989 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2020
Decision Date October 08, 2021
Days to Decision 448 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWM — Device, Monitoring, Intracranial Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1620

Similar Devices — GWM Device, Monitoring, Intracranial Pressure

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NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL
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