21 CFR 882.1900 — Stimulator, Auditory, Evoked Response
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1900
Identification
An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | 2 | 76 | 3rd Party |
