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Ambu A/S
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AMBU MARK IV BABY RESUSCITATOR is an FDA 510(k)-cleared medical device (K053142) manufactured by Ambu A/S. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 19, 2005. Regulation: 8.