MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM

MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM is an FDA 510(k)-cleared medical device (K983777) 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 December 17, 1998. Regulation: 8.