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Physiometrix, Inc.
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MODEL 4310 PSARRAY2 EEG ELECTRODE is an FDA 510(k)-cleared medical device (K020670) manufactured by Physiometrix, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 7, 2002. Regulation: 8.