The following data is part of a premarket notification filed by Wheel Checkers with the FDA for Modified Device For Self Examination Of Eyes.
| Device ID | K863429 |
| 510k Number | K863429 |
| Device Name: | MODIFIED DEVICE FOR SELF EXAMINATION OF EYES |
| Classification | Grid, Amsler |
| Applicant | WHEEL CHECKERS 2020 SOUTH BANNOCK STREET Denver , CO 80223 - |
| Contact | Gieskieng |
| Correspondent | Gieskieng WHEEL CHECKERS 2020 SOUTH BANNOCK STREET Denver , CO 80223 - |
| Product Code | HOQ |
| CFR Regulation Number | 886.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-04 |
| Decision Date | 1987-01-20 |