OPTISTAR MR INJECTOR SYSTEM

OPTISTAR MR INJECTOR SYSTEM is an FDA 510(k)-cleared medical device (K984088) manufactured by Mallinckrodt Inc., Liebel-Flarsheim Business. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 5, 1999. Regulation: 8.