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S.A. Instrumentation Difra
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EYETRACKER/IDEAS is an FDA 510(k)-cleared medical device (K070670) manufactured by S.A. Instrumentation Difra. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 17, 2007. Regulation: 8.