MODIFIED BETATRON IV INSULIN INFUSION SYSTEM

MODIFIED BETATRON IV INSULIN INFUSION SYSTEM is an FDA 510(k)-cleared medical device (K900498) manufactured by Cardiac Pacemakers, 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 February 22, 1990. Regulation: 8.