OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100

OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 is an FDA 510(k)-cleared medical device (K853786) manufactured by American Bentley. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 15, 1985. Regulation: 8.