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Ambu A/S
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AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE is an FDA 510(k)-cleared medical device (K093825) manufactured by Ambu A/S. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 12, 2010. Regulation: 8.