The following data is part of a premarket notification filed by Vimetrics,llc. with the FDA for Central Vision Analyzer Model 1000.
| Device ID | K100095 |
| 510k Number | K100095 |
| Device Name: | CENTRAL VISION ANALYZER MODEL 1000 |
| Classification | Chart, Visual Acuity |
| Applicant | VIMETRICS,LLC. 311 E. BALTIMORE AVE SUITE 100 Media, PA 19063 |
| Contact | Stephen H H Sinclair,md |
| Correspondent | Stephen H H Sinclair,md VIMETRICS,LLC. 311 E. BALTIMORE AVE SUITE 100 Media, PA 19063 |
| Product Code | HOX |
| CFR Regulation Number | 886.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-13 |
| Decision Date | 2010-05-10 |
| Summary: | summary |