510(k) K040113

SANDMAN SD20 AMPLIFIER by Eb Neuro S.P.A. — Product Code GWL

K040113 is an FDA 510(k) premarket notification submitted by Eb Neuro S.P.A. for the device "SANDMAN SD20 AMPLIFIER". The FDA issued a decision of Substantially Equivalent on February 18, 2004. 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.