510(k) K150220

STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast by Eb Neuro S.P.A. — Product Code GWF

K150220 is an FDA 510(k) premarket notification submitted by Eb Neuro S.P.A. for the device "STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast". The FDA issued a decision of Substantially Equivalent on August 19, 2015. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Eb Neuro S.P.A. has at least 10 other 510(k) clearances on record.