The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Vfs 1000/screening Function Analyzer.
| Device ID | K830011 |
| 510k Number | K830011 |
| Device Name: | VFS 1000/SCREENING FUNCTION ANALYZER |
| Classification | Chart, Visual Acuity |
| Applicant | COOPERVISION, INC. PERMALENS HOUSE 1 BOTLEY ROAD, HEDGE END Southampton, GB S033hb |
| Product Code | HOX |
| CFR Regulation Number | 886.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-03 |
| Decision Date | 1983-01-17 |