OPTEX BLOOD GAS MONITORING SYSTEM

OPTEX BLOOD GAS MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K896311) manufactured by Optex Biomedical. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 2, 1990. Regulation: 8.