21 CFR 882.1330 — Electrode, Depth
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1330
Identification
A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GZL | Electrode, Depth | 2 | 58 | 3rd Party |
