The following data is part of a premarket notification filed by Tomey Corporation Usa with the FDA for Video Vision Analyzer (viva), Vrb 100.
| Device ID | K945959 |
| 510k Number | K945959 |
| Device Name: | VIDEO VISION ANALYZER (VIVA), VRB 100 |
| Classification | Refractometer, Ophthalmic |
| Applicant | TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR Cambridge, MA 02139 |
| Contact | Mark Girardi |
| Correspondent | Mark Girardi TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR Cambridge, MA 02139 |
| Product Code | HKO |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-07 |
| Decision Date | 1995-03-01 |