H-3000 OXYGEN CONCENTRATOR

H-3000 OXYGEN CONCENTRATOR is an FDA 510(k)-cleared medical device (K890150) manufactured by Healthdyne, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 30, 1989. Regulation: 8.