510(k) K050720 ยท GWM Device, Monitoring, Intracranial Pressure
NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
| Applicant | Integra Neurosciences, Planisboro NJ, US |
| Decision | Substantially Equivalent, May 11, 2005 |
| Received | Mar 21, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050720
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2006 | Integra Neuro Sciences NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit Terminated |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.