MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M

MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M is an FDA 510(k)-cleared medical device (K896125) 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 January 31, 1990. Regulation: 8.