510(k) K152670

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables by Medos International SARL — Product Code GWM

K152670 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables". The FDA issued a decision of Substantially Equivalent on January 22, 2016. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Medos International SARL has at least 10 other 510(k) clearances on record.