STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964

STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 is an FDA 510(k)-cleared medical device (K990574) 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 May 23, 1999. Regulation: 8.