K182073 is an FDA 510(k) clearance for the BcSs-PICNI-2000 Sensor. 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. (Sao Carlos, BR). The FDA issued a Cleared decision on October 17, 2019, 442 days after receiving the submission on August 1, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1620.
| 510(k) Number | K182073 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2018 |
| Decision Date | October 17, 2019 |
| Days to Decision | 442 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 |