The following data is part of a premarket notification filed by Visidyne Corp. with the FDA for Chromops Fm-100 Color Vision Tester.
| Device ID | K810700 |
| 510k Number | K810700 |
| Device Name: | CHROMOPS FM-100 COLOR VISION TESTER |
| Classification | Tester, Color Vision |
| Applicant | VISIDYNE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HIT |
| CFR Regulation Number | 886.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-16 |
| Decision Date | 1981-04-10 |