510(k) K984524

AZTECH 70 by Villa Sistemi Medicali S.P.A. — Product Code EHD

K984524 is an FDA 510(k) premarket notification submitted by Villa Sistemi Medicali S.P.A. for the device "AZTECH 70". The FDA issued a decision of Substantially Equivalent on January 14, 1999. 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.