510(k) K120252

RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM by Raumedic AG — Product Code GWM

K120252 is an FDA 510(k) premarket notification submitted by Raumedic AG for the device "RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM". The FDA issued a decision of Substantially Equivalent on April 11, 2012. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Raumedic AG has at least 5 other 510(k) clearances on record.