510(k) K180779

Savina 300 by Dragerwerk AG & CO Kgaa — Product Code CBK

K180779 is an FDA 510(k) premarket notification submitted by Dragerwerk AG & CO Kgaa for the device "Savina 300". The FDA issued a decision of Substantially Equivalent on January 17, 2019. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Dragerwerk AG & CO Kgaa has at least 1 other 510(k) clearance on record.