510(k) K080582

MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA by Medicatech USA — Product Code KPR

K080582 is an FDA 510(k) premarket notification submitted by Medicatech USA for the device "MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA". The FDA issued a decision of Substantially Equivalent on May 15, 2008. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Medicatech USA has at least 9 other 510(k) clearances on record.