
Nellcor Puritan Bennett
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PURITAN BENNETT LEGENDAIR XL2 is an FDA 510(k)-cleared medical device (K070899) manufactured by Nellcor Puritan Bennett. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 2007. Regulation: 8.