K830011 is an FDA 510(k) clearance for the VFS 1000/SCREENING FUNCTION ANALYZER. This device is classified as a Chart, Visual Acuity (Class I - General Controls, product code HOX).
Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on January 17, 1983, 14 days after receiving the submission on January 3, 1983.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1150.
| 510(k) Number | K830011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 1983 |
| Decision Date | January 17, 1983 |
| Days to Decision | 14 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 |