COMFORTLITE NASAL MASK

COMFORTLITE NASAL MASK is an FDA 510(k)-cleared medical device (K082558) manufactured by Respironics, 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 24, 2009. Regulation: 8.