DATEX ENGSTOM MANUAL RESUSCITATOR

DATEX ENGSTOM MANUAL RESUSCITATOR is an FDA 510(k)-cleared medical device (K970991) manufactured by Promedic, 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 June 15, 1997. Regulation: 8.