510(k) K141869 ยท GWM Device, Monitoring, Intracranial Pressure
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
| Applicant | Hemedex Incorporated, Cambridge MA, US |
| Decision | Substantially Equivalent, Oct 10, 2014 |
| Received | Jul 11, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141869
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.