510(k) K222207

Babylog VN800, Babylog VN600 by Draegerwerk AG & CO Kgaa — Product Code CBK

K222207 is an FDA 510(k) premarket notification submitted by Draegerwerk AG & CO Kgaa for the device "Babylog VN800, Babylog VN600". 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.