510(k) K050720

NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 by Integra Neurosciences — Product Code GWM

K050720 is an FDA 510(k) premarket notification submitted by Integra Neurosciences for the device "NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100". The FDA issued a decision of Substantially Equivalent on May 11, 2005. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Integra Neurosciences has at least 8 other 510(k) clearances on record.