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Natus Medical Incorporated
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NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM is an FDA 510(k)-cleared medical device (K103589) manufactured by Natus Medical Incorporated. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 12, 2011. Regulation: 8.

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