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Alaris Medical Systems, Inc.
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MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE is an FDA 510(k)-cleared medical device (K022677) manufactured by Alaris Medical Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 2002. Regulation: 8.