SIMS HYPERINFLATION BAG SYSTEM

SIMS HYPERINFLATION BAG SYSTEM is an FDA 510(k)-cleared medical device (K970785) manufactured by Sims. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 12, 1997. Regulation: 8.