ALARIS SYSTEM PC UNIT, MODEL 8001

ALARIS SYSTEM PC UNIT, MODEL 8001 is an FDA 510(k)-cleared medical device (K051641) manufactured by Cardinal Health, Alaris Products. 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 October 19, 2005. Regulation: 8.