PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR

PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR is an FDA 510(k)-cleared medical device (K851435) 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.