510(k) K010422 ยท GWM Device, Monitoring, Intracranial Pressure
ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER
| Applicant | Innerspace, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Jun 28, 2001 |
| Received | Feb 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010422
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.