510(k) K071505 ยท GWM Device, Monitoring, Intracranial Pressure
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
| Applicant | Integra LifeSciences Corporation, Planisboro NJ, US |
| Decision | Substantially Equivalent, Aug 6, 2007 |
| Received | Jun 1, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071505
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2008 | Integra Neuro Sciences INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Integra NeuroSciences Terminated |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.