510(k) K062267

OXYLOG 3000 by Drager Medical B.V. — Product Code CBK

K062267 is an FDA 510(k) premarket notification submitted by Drager Medical B.V. for the device "OXYLOG 3000". The FDA issued a decision of Substantially Equivalent on October 31, 2006. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Drager Medical B.V. has at least 1 other 510(k) clearance on record.