510(k) K252241

Pressio 3 Multi-parameter Neuromonitoring System by Sophysa — Product Code GWM

K252241 is an FDA 510(k) premarket notification submitted by Sophysa for the device "Pressio 3 Multi-parameter Neuromonitoring System". The FDA issued a decision of Substantially Equivalent on April 10, 2026. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Sophysa has at least 10 other 510(k) clearances on record.