(348 days)
The Wireless EEG Recording System Model W32 is intended to amplify, filter and convert into digital values electrophysiological voltages (primarily EEG, EOG, EMG, and ECG) sensed by conventional skin surface electrodes which have been attached to the patient. These signals are then transmitted via radio waves to the receiver portion of the system which transfers them to a computer for display and evaluation by appropriate health professionals.
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§ 882.1855 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.