510(k) K062793

SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION by Maquet Critical Care AB — Product Code CBK

K062793 is an FDA 510(k) premarket notification submitted by Maquet Critical Care AB for the device "SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION". The FDA issued a decision of Substantially Equivalent on February 7, 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.