
Esaote Europe B.V.
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MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K061755) 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 6, 2006. Regulation: 8.