
E.M.S Electro Medical Systems S.A
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DEEP BLUE is an FDA 510(k)-cleared medical device (K071722) manufactured by E.M.S Electro Medical Systems S.A. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 9, 2007. Regulation: 8.