MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905

MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 is an FDA 510(k)-cleared medical device (K040892) manufactured by Nidek Medical Products, 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 28, 2004. Regulation: 8.