510(k) K032337 ยท GWM Device, Monitoring, Intracranial Pressure
HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
| Applicant | Hemedex Incorporated, Hopkonton MA, US |
| Decision | Substantially Equivalent, Oct 21, 2003 |
| Received | Jul 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032337
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.