510(k) K062584 ยท GWM Device, Monitoring, Intracranial Pressure
PRESSIO ICP MONITORING SYSTEM
| Applicant | Sophysa SA, Dana Point CA, US |
| Decision | Substantially Equivalent, Jul 5, 2007 |
| Received | Sep 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062584
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2024 | Sophysa S.A. The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricul Open, Classified |
GWM | None listed |
| May 15, 2024 | Sophysa S.A. The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use Open, Classified |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.