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Bio-Logic Systems Corp.
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MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM is an FDA 510(k)-cleared medical device (K031009) manufactured by Bio-Logic Systems Corp.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 27, 2003. Regulation: 8.