21 CFR 882.1855
§ 882.1855 Electroencephalogram (EEG) telemetry system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 882.1855, § 882.1855 Electroencephalogram (EEG) telemetry system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90667
- Permanent ID
ys:prov:90667@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.