510(k) K252241 ยท GWM Device, Monitoring, Intracranial Pressure
Pressio 3 Multi-parameter Neuromonitoring System
| Applicant | Sophysa, Orsay, FR |
| Decision | Substantially Equivalent, Apr 10, 2026 |
| Received | Jul 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252241
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.