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Hudson Respiratory Care, Inc.
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CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60 is an FDA 510(k)-cleared medical device (K001213) manufactured by Hudson Respiratory Care, 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 November 2, 2000. Regulation: 8.