PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03

PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 is an FDA 510(k)-cleared medical device (K093124) manufactured by Cardinal Health 207, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 9, 2010. Regulation: 8.