510(k) K113088 ยท GWM Device, Monitoring, Intracranial Pressure
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
| Applicant | Innerspace, Inc., Tustin CA, US |
| Decision | Substantially Equivalent, May 2, 2012 |
| Received | Oct 19, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113088
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.