510(k) K922079

ROTOLUX, SELECTOLUX, SHUTTERVUE by American Medical Sales, Inc. — Product Code IXC

K922079 is an FDA 510(k) premarket notification submitted by American Medical Sales, Inc. for the device "ROTOLUX, SELECTOLUX, SHUTTERVUE". The FDA issued a decision of Substantially Equivalent on June 16, 1992. The device falls under product code IXC (Illuminator, Radiographic-Film), a Class I device regulated under 21 CFR 892.1890. American Medical Sales, Inc. has at least 2 other 510(k) clearances on record.