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).

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