BARRIERFLEX-I, AND BARRIERFLES-II

BARRIERFLEX-I, AND BARRIERFLES-II is an FDA 510(k)-cleared medical device (K934189) manufactured by Bird Life Design. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 23, 1993. Regulation: 8.