ENVITEC MYSIGN O OXYGEN MEASURING DEVICE

ENVITEC MYSIGN O OXYGEN MEASURING DEVICE is an FDA 510(k)-cleared medical device (K122290) manufactured by Envitec-Wismar GmbH. 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 22, 2013. Regulation: 8.