NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN

NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN is an FDA 510(k)-cleared medical device (K813352) 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 January 6, 1982. Regulation: 8.