LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT

LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT is an FDA 510(k)-cleared medical device (K884018) manufactured by Lamelli Pulmonary Research Center. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 26, 1989. Regulation: 8.