510(k) K151814

SERVO-U Ventilator System, SERVO-n Ventilator System by Maquet Critical Care AB — Product Code CBK

K151814 is an FDA 510(k) premarket notification submitted by Maquet Critical Care AB for the device "SERVO-U Ventilator System, SERVO-n Ventilator System". The FDA issued a decision of Substantially Equivalent on December 21, 2015. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Maquet Critical Care AB has at least 10 other 510(k) clearances on record.