Submission Details
| 510(k) Number | K833956 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 16, 1983 |
| Decision Date | January 04, 1984 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
K833956 is an FDA 510(k) clearance for the DOT VISUAL ACVITY TEST 2000, a Chart, Visual Acuity (Class I — General Controls, product code HOX), submitted by Good-Lite Co. (Mchenry, US). The FDA issued a Cleared decision on January 4, 1984, 49 days after receiving the submission on November 16, 1983. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1150.
| 510(k) Number | K833956 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 16, 1983 |
| Decision Date | January 04, 1984 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HOX — Chart, Visual Acuity |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.1150 |