510(k) K973219

AMBER DU by Oldelft Corp. of America — Product Code KPR

K973219 is an FDA 510(k) premarket notification submitted by Oldelft Corp. of America for the device "AMBER DU". The FDA issued a decision of Substantially Equivalent on October 8, 1997. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Oldelft Corp. of America has at least 8 other 510(k) clearances on record.