510(k) K031086

CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 by Integra Neurosciences — Product Code GWM

K031086 is an FDA 510(k) premarket notification submitted by Integra Neurosciences for the device "CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1". The FDA issued a decision of Substantially Equivalent on May 14, 2003. 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.