21 CFR 882.1890 — Stimulator, Photic, Evoked Response
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1890
Identification
An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GWE | Stimulator, Photic, Evoked Response | 2 | 49 | 3rd Party |
