21 C.F.R. § 882.1320 Cutaneous electrode.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart B—Neurological Diagnostic Devices
§ 882.1320 Cutaneous electrode.

