MEDIPART XENON BREATHING KIT MP-OIXM-I

MEDIPART XENON BREATHING KIT MP-OIXM-I is an FDA 510(k)-cleared medical device (K850366) 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 April 29, 1985. Regulation: 8.