MEDIPART XENON BREATHING KIT MP-01XM

MEDIPART XENON BREATHING KIT MP-01XM is an FDA 510(k)-cleared medical device (K844496) manufactured by Medipart Jerry Alexander. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 23, 1984. Regulation: 8.