HYGEIA-5 OXYGEN CONCENTRATOR

HYGEIA-5 OXYGEN CONCENTRATOR is an FDA 510(k)-cleared medical device (K081267) manufactured by Kedl Internation Limited. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 22, 2008. Regulation: 8.