510(k) K081743

CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS by Draeger Medical AG & Co. KG — Product Code CBK

K081743 is an FDA 510(k) premarket notification submitted by Draeger Medical AG & Co. KG for the device "CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS". The FDA issued a decision of Substantially Equivalent on September 22, 2008. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Draeger Medical AG & Co. KG has at least 9 other 510(k) clearances on record.