510(k) K161468

Transformair Indoor Air Purifier by Transformair, LLC — Product Code FRA

K161468 is an FDA 510(k) premarket notification submitted by Transformair, LLC for the device "Transformair Indoor Air Purifier". The FDA issued a decision of Substantially Equivalent on February 8, 2017. The device falls under product code FRA (Purifier, Air, Ultraviolet, Medical), a Class II device regulated under 21 CFR 880.6500.