RESPIRONICS MONARCH MINI MASK

RESPIRONICS MONARCH MINI MASK is an FDA 510(k)-cleared medical device (K945938) 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 January 30, 1996. Regulation: 8.