510(k) K912139 ยท GWM Device, Monitoring, Intracranial Pressure
MODEL 704
| Applicant | Ivy Biomedical Systems, Inc., Branford CT, US |
| Decision | Substantially Equivalent, Mar 25, 1992 |
| Received | May 14, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912139
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.