PRIME AIRE O2 PLUS 2

PRIME AIRE O2 PLUS 2 is an FDA 510(k)-cleared medical device (K851437) manufactured by Invacare Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 28, 1985. Regulation: 8.