510(k) K954448

VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM by Schiff & Co. — Product Code FRA

K954448 is an FDA 510(k) premarket notification submitted by Schiff & Co. for the device "VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 28, 1996. The device falls under product code FRA (Purifier, Air, Ultraviolet, Medical), a Class II device regulated under 21 CFR 880.6500. Schiff & Co. has at least 10 other 510(k) clearances on record.