510(k) K063404

SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 by Maquet Critical Care AB — Product Code CBK

K063404 is an FDA 510(k) premarket notification submitted by Maquet Critical Care AB for the device "SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800". The FDA issued a decision of Substantially Equivalent on February 15, 2007. 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.