510(k) K041223

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

K041223 is an FDA 510(k) premarket notification submitted by Maquet Critical Care AB for the device "MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E". The FDA issued a decision of Substantially Equivalent on July 29, 2004. 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.