510(k) K082600

OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) by Draeger Medical B.V. — Product Code CBK

K082600 is an FDA 510(k) premarket notification submitted by Draeger Medical B.V. for the device "OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)". The FDA issued a decision of Substantially Equivalent on November 26, 2008. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Draeger Medical B.V. has at least 10 other 510(k) clearances on record.