POINT-OF-CARE BLOOD GAS MONITOR SYSTEM

POINT-OF-CARE BLOOD GAS MONITOR SYSTEM is an FDA 510(k)-cleared medical device (K961790) manufactured by Optical Sensors, 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 April 8, 1997. Regulation: 8.