Model X-100C CO-Met™ Oximetry System

Model X-100C CO-Met™ Oximetry System is an FDA 510(k)-cleared medical device (K160231) manufactured by Nonin Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 22, 2016. Regulation: 8.