510(k) K253647

Evita (V800); Evita (V600) by Draegerwerk AG & CO Kgaa — Product Code CBK

K253647 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 7, 2026. 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.