MODIFIED CLAIMS FOR FEF(TM) END-TIDAL CO2 DETECTOR

MODIFIED CLAIMS FOR FEF(TM) END-TIDAL CO2 DETECTOR is an FDA 510(k)-cleared medical device (K894429) manufactured by Fenem, 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 September 17, 1989. Regulation: 8.