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Esaote Europe B.V.
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MYLABONE ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K101605) manufactured by Esaote Europe B.V.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 2010. Regulation: 8.