MEDLEY PCA MODULE, MODEL 8120

MEDLEY PCA MODULE, MODEL 8120 is an FDA 510(k)-cleared medical device (K043299) manufactured by Alaris Medical Systems, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 9, 2004. Regulation: 8.