510(k) K230173

Servo-air Lite Ventilator System by Maquet Critical Care AB — Product Code MNT

K230173 is an FDA 510(k) premarket notification submitted by Maquet Critical Care AB for the device "Servo-air Lite Ventilator System". The FDA issued a decision of Substantially Equivalent on July 6, 2023. The device falls under product code MNT (Sv70 Ventilator), a Class II device regulated under 21 CFR 868.5895. Maquet Critical Care AB has at least 10 other 510(k) clearances on record.