510(k) K021573

PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION by Puritan-Bennett — Product Code CBK

K021573 is an FDA 510(k) premarket notification submitted by Puritan-Bennett for the device "PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION". The FDA issued a decision of ST on August 13, 2002. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Puritan-Bennett has at least 3 other 510(k) clearances on record.