CERION OXY THRESHOLD ALARM

CERION OXY THRESHOLD ALARM is an FDA 510(k)-cleared medical device (K880448) manufactured by Ceramatec, 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 March 20, 1988. Regulation: 8.