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Smiths Medical Asd, Inc.
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THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012 is an FDA 510(k)-cleared medical device (K092256) manufactured by Smiths Medical Asd, 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 October 19, 2010. Regulation: 8.