510(k) K072885

CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 by Draeger Medical AG & Co. KG — Product Code CBK

K072885 is an FDA 510(k) premarket notification submitted by Draeger Medical AG & Co. KG for the device "CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110". The FDA issued a decision of Substantially Equivalent on April 7, 2008. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Draeger Medical AG & Co. KG has at least 9 other 510(k) clearances on record.