CERION HAND HELD OXYGEN ANALYZER

CERION HAND HELD OXYGEN ANALYZER is an FDA 510(k)-cleared medical device (K911344) 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 June 17, 1991. Regulation: 8.