The following data is part of a premarket notification filed by Eyedex with the FDA for Eyetech-vision Screening System.
| Device ID | K803256 |
| 510k Number | K803256 |
| Device Name: | EYETECH-VISION SCREENING SYSTEM |
| Classification | Chart, Visual Acuity |
| Applicant | EYEDEX 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HOX |
| CFR Regulation Number | 886.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-23 |
| Decision Date | 1981-03-04 |