Code of Federal Regulations · Section
§ 882.1320 — Cutaneous Electrode
21 C.F.R. § 882.1320
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(a) Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351