510(k) K984535

PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION by Puritan Bennett Corp. — Product Code CBK

K984535 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION". The FDA issued a decision of ST on December 28, 1998. 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.