510(k) K943521

VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE by Schiff & Co. — Product Code FRA

K943521 is an FDA 510(k) premarket notification submitted by Schiff & Co. for the device "VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE". The FDA issued a decision of Substantially Equivalent on February 14, 1995. 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.