510(k) K900211

SKYTRON UNIVERSE SERIES SURGICAL LIGHTS by Skytron, Div. the Kmw Group, Inc. — Product Code FSY

K900211 is an FDA 510(k) premarket notification submitted by Skytron, Div. the Kmw Group, Inc. for the device "SKYTRON UNIVERSE SERIES SURGICAL LIGHTS". The FDA issued a decision of Substantially Equivalent on March 19, 1990. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Skytron, Div. the Kmw Group, Inc. has at least 10 other 510(k) clearances on record.