STERILE CAST PADDING
Device Facts
| Record ID | K801554 |
|---|---|
| Device Name | STERILE CAST PADDING |
| Applicant | Medi-Spec |
| Product Code | HIX · Ophthalmic |
| Decision Date | Aug 4, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1435 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A Maxwell spot is an AC-powered device that is a light source with a red and blue filter intended to test macular function.