ETV, ELECTRONIC VISION AID
Device Facts
| Record ID | K884540 |
|---|---|
| Device Name | ETV, ELECTRONIC VISION AID |
| Applicant | Sevrain-Tech, Inc. |
| Product Code | HPE · Ophthalmic |
| Decision Date | Jan 19, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5915 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An optical vision aid is a device that consists of a magnifying lens with an accompanying AC-powered or battery-powered light source intended for use by a patient who has impaired vision to increase the apparent size of object detail.
