510(k) K133517

NEMUS 2 SYSTEM by Eb Neuro S.P.A. — Product Code GWL

K133517 is an FDA 510(k) premarket notification submitted by Eb Neuro S.P.A. for the device "NEMUS 2 SYSTEM". The FDA issued a decision of Substantially Equivalent on February 26, 2014. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Eb Neuro S.P.A. has at least 10 other 510(k) clearances on record.