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Alaris Medical Systems, Inc.
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MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 is an FDA 510(k)-cleared medical device (K031741) manufactured by Alaris Medical Systems, 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 February 8, 2004. Regulation: 8.