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Neuro Scan Labs
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SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS) is an FDA 510(k)-cleared medical device (K001324) manufactured by Neuro Scan Labs. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 10, 2000. Regulation: 8.