510(k) K003154

MIZAR, BASIS BE, SANDMAN DIGITAL by Eb Neuro S.P.A. — Product Code GWL

K003154 is an FDA 510(k) premarket notification submitted by Eb Neuro S.P.A. for the device "MIZAR, BASIS BE, SANDMAN DIGITAL". The FDA issued a decision of Substantially Equivalent on January 5, 2001. 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.