Electroencephalogram (EEG) telemetry system.

(a) Identification. An electroencephalogram (EEG) telemetry system consists of transmitters, receivers, and other components used for remotely monitoring or measuring EEG signals by means of radio or telephone transmission systems. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. [44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]