K201989 is an FDA 510(k) clearance for the B4C System. This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Braincare Desenvolvimento E Inovacao Tecnologica S.A. (São 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 FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K201989 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | GWM - Device, Monitoring, Intracranial Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1620 |