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Physiometrix, Inc.
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MODEL 4000 EEG MONITOR WITH PSI (PSA4000) is an FDA 510(k)-cleared medical device (K001069) 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 June 29, 2000. Regulation: 8.