510(k) K153748

AirLife Misty Finity Nebulizer by Care Fusion — Product Code CAF

K153748 is an FDA 510(k) premarket notification submitted by Care Fusion for the device "AirLife Misty Finity Nebulizer". The FDA issued a decision of Substantially Equivalent on May 17, 2017. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Care Fusion has at least 10 other 510(k) clearances on record.