510(k) K151303

AirLife Infant Heated Wire Circuit by Care Fusion — Product Code BZE

K151303 is an FDA 510(k) premarket notification submitted by Care Fusion for the device "AirLife Infant Heated Wire Circuit". The FDA issued a decision of Substantially Equivalent on January 21, 2016. The device falls under product code BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer), a Class II device regulated under 21 CFR 868.5270. Care Fusion has at least 10 other 510(k) clearances on record.