21 CFR 882.1320 — Electrode, Cutaneous
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1320
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | 2 | 433 | 3rd Party |
