510(k) K070899

PURITAN BENNETT LEGENDAIR XL2 by Nellcor Puritan Bennett — Product Code CBK

K070899 is an FDA 510(k) premarket notification submitted by Nellcor Puritan Bennett for the device "PURITAN BENNETT LEGENDAIR XL2". The FDA issued a decision of Substantially Equivalent on December 13, 2007. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Nellcor Puritan Bennett has at least 10 other 510(k) clearances on record.