XENON XE 127/XE 133 GAS DISPENSER

XENON XE 127/XE 133 GAS DISPENSER is an FDA 510(k)-cleared medical device (K843640) manufactured by Mallinckrodt Critical Care. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 13, 1985. Regulation: 8.