510(k) K093633

INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE by Draegerwerk AG & CO Kgaa — Product Code CBK

K093633 is an FDA 510(k) premarket notification submitted by Draegerwerk AG & CO Kgaa for the device "INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE". The FDA issued a decision of Substantially Equivalent on March 30, 2010. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Draegerwerk AG & CO Kgaa has at least 7 other 510(k) clearances on record.