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Envitec-Wismar GmbH
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ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 is an FDA 510(k)-cleared medical device (K082655) 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 November 24, 2008. Regulation: 8.