OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)

OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) is an FDA 510(k)-cleared medical device (K941793) manufactured by Mountain Medical Equipment, 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 June 20, 1995. Regulation: 8.