
Esaote, S.p.A.
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MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) is an FDA 510(k)-cleared medical device (K081386) manufactured by Esaote, S.p.A.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 24, 2008. Regulation: 8.