MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER

MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER is an FDA 510(k)-cleared medical device (K863532) manufactured by Parker Hannifin Corp.. 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 January 13, 1987. Regulation: 8.