21 CFR 882.1310 — Electrode, Cortical
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1310
Identification
A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GYC | Electrode, Cortical | 2 | 32 | 3rd Party |
