TROPIC AIR HEAT-ECHANGER BREATHING AID

TROPIC AIR HEAT-ECHANGER BREATHING AID is an FDA 510(k)-cleared medical device (K821735) manufactured by Tropic Air. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 6, 1982. Regulation: 8.