The following data is part of a premarket notification filed by Nyx Golf, Inc. with the FDA for Nyx Golf Vision System.
| Device ID | K953245 |
| 510k Number | K953245 |
| Device Name: | NYX GOLF VISION SYSTEM |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | NYX GOLF, INC. 5010 PURDUE Dallas, TX 75209 |
| Contact | Clifton Beane |
| Correspondent | Clifton Beane NYX GOLF, INC. 5010 PURDUE Dallas, TX 75209 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-07 |
| Decision Date | 1995-07-19 |