VIDEO VISION ANALYZER (VIVA), VRB 100
Device Facts
| Record ID | K945959 |
|---|---|
| Device Name | VIDEO VISION ANALYZER (VIVA), VRB 100 |
| Applicant | Tomey Corporation USA |
| Product Code | HKO · Ophthalmic |
| Decision Date | Mar 1, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1760 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.