ORION BIOFEEDBACK DATA ACQUISITION

ORION BIOFEEDBACK DATA ACQUISITION is an FDA 510(k)-cleared medical device (K840223) manufactured by Self Regulation Systems, 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 March 8, 1984. Regulation: 8.