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Compumedics Neuro Science Pty , Ltd.
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COMPUMEDICS E-SERIES EEG SYSTEM is an FDA 510(k)-cleared medical device (K000068) manufactured by Compumedics Neuro Science Pty , Ltd.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 2000. Regulation: 8.