The following data is part of a premarket notification filed by Wheel Checkers with the FDA for Apparatus & Methods Self-exam Of Eye.
| Device ID | K843702 |
| 510k Number | K843702 |
| Device Name: | APPARATUS & METHODS SELF-EXAM OF EYE |
| Classification | Grid, Amsler |
| Applicant | WHEEL CHECKERS 2020 SOUTH BANNOCK STREET Denver , CO 80223 - |
| Contact | Giesking |
| Correspondent | Giesking 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 | 1984-09-21 |
| Decision Date | 1985-01-03 |