The following data is part of a premarket notification filed by Vistech Consultants, Inc. with the FDA for Mct 8000 (multi-vision Contrast Tester).
| Device ID | K881059 |
| 510k Number | K881059 |
| Device Name: | MCT 8000 (MULTI-VISION CONTRAST TESTER) |
| Classification | Chart, Visual Acuity |
| Applicant | VISTECH CONSULTANTS, INC. 1372 NOTH FAIRFIELD RD. Dayton, OH 45432 |
| Contact | Dennis J Mccreight |
| Correspondent | Dennis J Mccreight 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 | 1988-03-11 |
| Decision Date | 1988-04-04 |