21 CFR 882.1350 — Electrode, Needle
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1350
Identification
A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXZ | Electrode, Needle | 2 | 53 | 3rd Party |
