510(k) K201989 · GWM Device, Monitoring, Intracranial Pressure
B4C System
| Applicant | Braincare Desenvolvimento E Inovacao Tecnologica S.A., São Carlos, BR |
| Decision | Substantially Equivalent, Oct 8, 2021 |
| Received | Jul 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201989
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.