HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2

HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 is an FDA 510(k)-cleared medical device (K991569) manufactured by 02 Marketing Group, 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 August 2, 1999. Regulation: 8.