NE-U04/NE U04F

NE-U04/NE U04F is an FDA 510(k)-cleared medical device (K923024) manufactured by Omron Healthcare, 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 September 14, 1992. Regulation: 8.