H-500 ALLIANCE OXYGEN CONCENTRATOR

H-500 ALLIANCE OXYGEN CONCENTRATOR is an FDA 510(k)-cleared medical device (K942357) 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 May 26, 1994. Regulation: 8.