510(k) K061996

SANDMAN POCKET by Eb Neuro S.P.A. — Product Code MNR

K061996 is an FDA 510(k) premarket notification submitted by Eb Neuro S.P.A. for the device "SANDMAN POCKET". The FDA issued a decision of Substantially Equivalent on October 3, 2006. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Eb Neuro S.P.A. has at least 10 other 510(k) clearances on record.