510(k) K130702

AIRSONETT AIR-4 by Airsonett AB — Product Code FRF

K130702 is an FDA 510(k) premarket notification submitted by Airsonett AB for the device "AIRSONETT AIR-4". The FDA issued a decision of Substantially Equivalent on July 23, 2013. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045. Airsonett AB has at least 1 other 510(k) clearance on record.