ALARIS PC UNIT, MODELS 8000 AND 8015

ALARIS PC UNIT, MODELS 8000 AND 8015 is an FDA 510(k)-cleared medical device (K091308) manufactured by Cardinal Health 303,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 July 8, 2009. Regulation: 8.