The following data is part of a premarket notification filed by Vistech Consultants, Inc. with the FDA for Vistech Vcts Glare Tester.
| Device ID | K853481 |
| 510k Number | K853481 |
| Device Name: | VISTECH VCTS GLARE TESTER |
| Classification | Chart, Visual Acuity |
| Applicant | VISTECH CONSULTANTS, INC. 1372 NOTH FAIRFIELD RD. Dayton, OH 45432 |
| Contact | Ken Blarvelt |
| Correspondent | Ken Blarvelt VISTECH CONSULTANTS, INC. 1372 NOTH FAIRFIELD RD. Dayton, OH 45432 |
| Product Code | HOX |
| CFR Regulation Number | 886.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-20 |
| Decision Date | 1985-10-29 |