510(k) K063650

VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 by Puritan Bennett Corp. — Product Code CBK

K063650 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840". 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. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.