CRYSTAL-EEG MODEL 10 (MODEL 10)

CRYSTAL-EEG MODEL 10 (MODEL 10) is an FDA 510(k)-cleared medical device (K970672) manufactured by Cleveland Medical Devices, 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 May 21, 1997. Regulation: 8.