510(k) K052943

DDRFORMULA AND DDRFORMULA PLUS by Swissray Medical AG — Product Code KPR

K052943 is an FDA 510(k) premarket notification submitted by Swissray Medical AG for the device "DDRFORMULA AND DDRFORMULA PLUS". The FDA issued a decision of Substantially Equivalent on Dec 15, 2005. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Swissray Medical AG has at least 3 other 510(k) clearances on record.