
Nidek Medical Products, Inc.
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MARK 5 NUVO LITE OCSI AND STD is an FDA 510(k)-cleared medical device (K082566) 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 December 2, 2008. Regulation: 8.