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Respironics Novametrix, LLC
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LOFLO C5 CO2 SENSOR is an FDA 510(k)-cleared medical device (K053174) manufactured by Respironics Novametrix, LLC. 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 11, 2006. Regulation: 8.