K863429 is an FDA 510(k) clearance for the MODIFIED DEVICE FOR SELF EXAMINATION OF EYES. This device is classified as a Grid, Amsler (Class I - General Controls, product code HOQ).
Submitted by Wheel Checkers (Denver, US). The FDA issued a Cleared decision on January 20, 1987, 138 days after receiving the submission on September 4, 1986.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1330.
| 510(k) Number | K863429 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 1986 |
| Decision Date | January 20, 1987 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HOQ — Grid, Amsler |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1330 |