DISP. HYPERINFLATION BAG SYSTEM

DISP. HYPERINFLATION BAG SYSTEM is an FDA 510(k)-cleared medical device (K813317) manufactured by Intec Medical, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 11, 1982. Regulation: 8.