MONITOR, OXYGEN, MODEL 3000A

MONITOR, OXYGEN, MODEL 3000A is an FDA 510(k)-cleared medical device (K781209) manufactured by Oxyair Engineering, 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 August 13, 1978. Regulation: 8.