RAE(R) II TRACHEAL TUBE

RAE(R) II TRACHEAL TUBE is an FDA 510(k)-cleared medical device (K932280) manufactured by Mallinckrodt Medical. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 7, 1993. Regulation: 8.