510(k) K761018

SURGICAL LIGHT - CHALLENGE 22 SERIES by Amsco Co. — Product Code FQP

K761018 is an FDA 510(k) premarket notification submitted by Amsco Co. for the device "SURGICAL LIGHT - CHALLENGE 22 SERIES". The FDA issued a decision of Substantially Equivalent on January 26, 1977. The device falls under product code FQP (Lamp, Operating-Room), a Class II device regulated under 21 CFR 878.4580. Amsco Co. has at least 10 other 510(k) clearances on record.