DISPOSABLE RESPIRTORY KIT (MP-200)

DISPOSABLE RESPIRTORY KIT (MP-200) is an FDA 510(k)-cleared medical device (K896885) 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 February 25, 1990. Regulation: 8.