510(k) K201220

Aerus Medical Guardian,model F170A by Aerus Medical, LLC — Product Code FRA

K201220 is an FDA 510(k) premarket notification submitted by Aerus Medical, LLC for the device "Aerus Medical Guardian,model F170A". The FDA issued a decision of Substantially Equivalent on June 17, 2020. The device falls under product code FRA (Purifier, Air, Ultraviolet, Medical), a Class II device regulated under 21 CFR 880.6500.