Instrumentation Difra
The videonystagmoscope transcribes the image of the patient's eye on a computer screen. The VIDEOSTAR can thus assess the reactions of the patient viewing his nystagmus during testing…
The videonystagmoscope transcribes the image of the patient’s eye on a computer screen. The VIDEOSTAR can thus assess the reactions of the patient viewing his nystagmus during testing positions, caloric, rotary or due to any other stimulus. The camera can be placed in front of the patient’s right or left eye. The camera is fixed on a mask, fitting the line of the patient’s face in order to occult completely from the outside light. The second eye view is either closed by an eyepiece or let free, which leaves it a free view. TECHNICAL SPECIFICATION: USB 2.0 connection 30 frames/s Resolution: 640 x 480 pixels Cable of 5 meters Compatible Windows Seven/8 – 32 or 64 bits
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wenzhou Eugenia Eyewear Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 6 |
Record
| Listed by | Instrumentation Difra SA |
|---|---|
| FDA product code | HJJ |
| Device type | Lens, Fresnel, Flexible, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1390 |
| Premarket notification | Exempt |
| Record published | 2018-09-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Contains natural rubber latex |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VIDEOSTAR II | In distribution | |
| VIDEOSTAR | In distribution |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.