MYLAB30, MODEL 7300

MYLAB30, MODEL 7300 is an FDA 510(k)-cleared medical device (K071996) 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 August 2, 2007. Regulation: 8.