510(k) K170378

AirLife Adult Heated Wire BiPAP/NIV Circuit by Vyaire Medical — Product Code BZE

K170378 is an FDA 510(k) premarket notification submitted by Vyaire Medical for the device "AirLife Adult Heated Wire BiPAP/NIV Circuit". The FDA issued a decision of Substantially Equivalent on September 14, 2017. 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. Vyaire Medical has at least 10 other 510(k) clearances on record.