510(k) K053388

MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION by Puritan Bennett Corp. — Product Code CBK

K053388 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION". The FDA issued a decision of Substantially Equivalent on April 4, 2006. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.