AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT

AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT is an FDA 510(k)-cleared medical device (K910040) 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 27, 1991. Regulation: 8.