
Neurognostics, Inc.
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MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0 is an FDA 510(k)-cleared medical device (K052571) manufactured by Neurognostics, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 16, 2005. Regulation: 8.