510(k) K103625

OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE by Draeger Medical Systems, Inc. — Product Code CBK

K103625 is an FDA 510(k) premarket notification submitted by Draeger Medical Systems, Inc. for the device "OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE". The FDA issued a decision of Substantially Equivalent on October 6, 2011. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Draeger Medical Systems, Inc. has at least 10 other 510(k) clearances on record.