510(k) K222024

Evita V800, Evita V600 by Draegerwerk AG & CO Kgaa — Product Code CBK

K222024 is an FDA 510(k) premarket notification submitted by Draegerwerk AG & CO Kgaa for the device "Evita V800, Evita V600". The FDA issued a decision of Substantially Equivalent on May 16, 2023. 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.