The following data is part of a premarket notification filed by Eyesys Technologies, Inc. with the FDA for Eye Sys Vista.
| Device ID | K973756 |
| 510k Number | K973756 |
| Device Name: | EYE SYS VISTA |
| Classification | Keratoscope, Ac-powered |
| Applicant | EYESYS TECHNOLOGIES, INC. 2776 BINGLE Houston, TX 77055 |
| Contact | Beth A Soper |
| Correspondent | Beth A Soper EYESYS TECHNOLOGIES, INC. 2776 BINGLE Houston, TX 77055 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-02 |
| Decision Date | 1997-11-13 |