510(k) K121886

SAVINA 300 SAVINA 300, COUNTRY VARIANTS by Draeger Medical GmbH — Product Code CBK

K121886 is an FDA 510(k) premarket notification submitted by Draeger Medical GmbH for the device "SAVINA 300 SAVINA 300, COUNTRY VARIANTS". The FDA issued a decision of Substantially Equivalent on August 8, 2014. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Draeger Medical GmbH has at least 10 other 510(k) clearances on record.