MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD

MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD is an FDA 510(k)-cleared medical device (K093308) 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 January 13, 2010. Regulation: 8.