CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615

CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615 is an FDA 510(k)-cleared medical device (K982243) manufactured by Canogen International , Ltd.. 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 18, 1998. Regulation: 8.