510(k) K945585 ยท GWM Device, Monitoring, Intracranial Pressure
COMAN(R) CU-11 MODEL NUMBER 82-6634
| Applicant | Johnson & Johnson Professionals, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Oct 26, 1995 |
| Received | Nov 14, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945585
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.