K840255 is an FDA 510(k) clearance for the VISTECH VCTS 6000. This device is classified as a Chart, Visual Acuity (Class I — General Controls, product code HOX).
Submitted by Vistech Consultants, Inc. (Walker, US). The FDA issued a Cleared decision on April 13, 1984, 81 days after receiving the submission on January 23, 1984.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1150.
| 510(k) Number | K840255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1984 |
| Decision Date | April 13, 1984 |
| Days to Decision | 81 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 |