510(k) K920194

ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN by E.I. Dupont DE Nemours & Co., Inc. — Product Code EAM

K920194 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN". The FDA issued a decision of Substantially Equivalent on May 27, 1992. The device falls under product code EAM (Screen, Intensifying, Radiographic), a Class I device regulated under 21 CFR 892.1960. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.