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Cardinal Health 207, Inc.
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HELIOX LOW FLOW SENTRY BLENDER is an FDA 510(k)-cleared medical device (K092484) manufactured by Cardinal Health 207, 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 April 1, 2010. Regulation: 8.