510(k) K102618

VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED by Draeger Medical AG & Co. KG — Product Code BTT

K102618 is an FDA 510(k) premarket notification submitted by Draeger Medical AG & Co. KG for the device "VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED". The FDA issued a decision of Substantially Equivalent on December 10, 2010. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Draeger Medical AG & Co. KG has at least 9 other 510(k) clearances on record.