MODIFIED ENDOBRONCHIAL TUBE

MODIFIED ENDOBRONCHIAL TUBE is an FDA 510(k)-cleared medical device (K902116) manufactured by Concord/Portex. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 2, 1990. Regulation: 8.