510(k) K162108

Pressio 2 ICP Monitoring System by Sophysa SA — Product Code GWM

K162108 is an FDA 510(k) premarket notification submitted by Sophysa SA for the device "Pressio 2 ICP Monitoring System". The FDA issued a decision of Substantially Equivalent on April 17, 2017. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Sophysa SA has at least 10 other 510(k) clearances on record.