510(k) K883518

EVENT MARKER & A SECOND PRESSURE TREND OUTPUT by Metatech Corp. — Product Code GWM

K883518 is an FDA 510(k) premarket notification submitted by Metatech Corp. for the device "EVENT MARKER & A SECOND PRESSURE TREND OUTPUT". The FDA issued a decision of Substantially Equivalent on September 22, 1988. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Metatech Corp. has at least 10 other 510(k) clearances on record.