21 CFR 882.1870 — Stimulator, Electrical, Evoked Response
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1870
Identification
An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | 2 | 139 | 3rd Party |
| NTU | Evoked Potential Stimulator, Thermal | 2 | 3 | 3rd Party |
