ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY

ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY is an FDA 510(k)-cleared medical device (K851245) manufactured by Applinc. 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 14, 1985. Regulation: 8.