K240821 is an FDA 510(k) clearance for the B4C System - Addition of new sensor model (BcSs-PICNIW-2000). This device is classified as a Device, Monitoring, Intracranial Pressure (Class II - Special Controls, product code GWM).
Submitted by Braincare Desenvolvimento E Inova??o Tecnol?gica S.A. (São Carlos, BR). The FDA issued a Cleared decision on July 18, 2024, 115 days after receiving the submission on March 25, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K240821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2024 |
| Decision Date | July 18, 2024 |
| Days to Decision | 115 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 |