AMBU NEONATE SILICONE RESUSCITATOR

AMBU NEONATE SILICONE RESUSCITATOR is an FDA 510(k)-cleared medical device (K993278) manufactured by Ambu, 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 May 16, 2000. Regulation: 8.