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Activaero America, Inc.
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AKITA2 APIXNEB is an FDA 510(k)-cleared medical device (K072019) manufactured by Activaero America, 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 November 4, 2007. Regulation: 8.