21 CFR § 882.1320 Neurological Devices

§ 882.1320 Cutaneous electrode.

Current through Sep 8, 2026 · Read all of Part 882

⚠ 2 pending changes to Part 882

(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).

← § 882.1310 Cortical electrode.§ 882.1330 Depth electrode. →