POLARON
Device Facts
| Record ID | K902187 |
|---|---|
| Device Name | POLARON |
| Applicant | Nurion Industries |
| Product Code | HPG · Ophthalmic |
| Decision Date | Aug 8, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5900 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An electronic vision aid is an AC-powered or battery-powered device that consists of an electronic sensor/transducer intended for use by a patient who has impaired vision or blindness to translate visual images of objects into tactile or auditory signals.
