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Ambu A/S
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AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X is an FDA 510(k)-cleared medical device (K100129) manufactured by Ambu A/S. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 10, 2010. Regulation: 8.