SPECTACLE, MAGNIFYING
Device Facts
| Record ID | K873967 |
|---|---|
| Device Name | SPECTACLE, MAGNIFYING |
| Applicant | Swank Plus , Ltd. |
| Product Code | HOT · Ophthalmic |
| Decision Date | Feb 26, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5910 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An image intensification vision aid is a battery-powered device intended for use by a patient who has limited dark adaptation or impaired vision to amplify ambient light.
