510(k) K182073 ยท GWM Device, Monitoring, Intracranial Pressure
BcSs-PICNI-2000 Sensor
| Applicant | Braincare Desenvolvimento E Inovacao Tecnologica S.A., Sao Carlos, BR |
| Decision | Substantially Equivalent, Oct 17, 2019 |
| Received | Aug 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182073
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.