510(k) K030185

ENDOS AC/ACP by Villa Sistemi Medicali S.P.A. — Product Code EHD

K030185 is an FDA 510(k) premarket notification submitted by Villa Sistemi Medicali S.P.A. for the device "ENDOS AC/ACP". The FDA issued a decision of Substantially Equivalent on March 11, 2003. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Villa Sistemi Medicali S.P.A. has at least 10 other 510(k) clearances on record.