510(k) K070722

PLASMAIR, MODEL T2006 by Airinspace B.V. — Product Code FRF

K070722 is an FDA 510(k) premarket notification submitted by Airinspace B.V. for the device "PLASMAIR, MODEL T2006". The FDA issued a decision of Substantially Equivalent on December 14, 2007. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045.