510(k) K030634

ENDOS DC by Villa Sistemi Medicali S.P.A. — Product Code EHD

K030634 is an FDA 510(k) premarket notification submitted by Villa Sistemi Medicali S.P.A. for the device "ENDOS DC". The FDA issued a decision of Substantially Equivalent on July 21, 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.