
Eyetect, LLC
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EYETECT TREMOR MONITOR UNIT (TMU) is an FDA 510(k)-cleared medical device (K003644) manufactured by Eyetect, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 31, 2001. Regulation: 8.