510(k) K201874

Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 by Maquet Critical Care AB — Product Code CBK

K201874 is an FDA 510(k) premarket notification submitted by Maquet Critical Care AB for the device "Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1". The FDA issued a decision of Substantially Equivalent on April 20, 2021. 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.