TRANSCUTANEOUS 800-OXYGEN MONITORS/801

TRANSCUTANEOUS 800-OXYGEN MONITORS/801 is an FDA 510(k)-cleared medical device (K840993) manufactured by Novametrix Medical Systems, 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 23, 1984. Regulation: 8.