510(k) K060705

CARINA HOME by Draeger Medical B.V. — Product Code CBK

K060705 is an FDA 510(k) premarket notification submitted by Draeger Medical B.V. for the device "CARINA HOME". The FDA issued a decision of Substantially Equivalent on June 14, 2006. 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.