510(k) K001646

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

K001646 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION". The FDA issued a decision of ST on October 20, 2000. 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.