The Vision Monitor MonCvONE system is a non-invasive medical device used to generate photic stimulations and to register the responses including electrical responses generated by the retina…
The Vision Monitor MonCvONE system is a non-invasive medical device used to generate photic stimulations and to register the responses including electrical responses generated by the retina and the visual nervous system in addition to psychophysical and pupillary responses. It displays digitized electroretinogram (ERG), visual evoked potential (VEP), sensory electro-oculogram (EOG), light and dark adapted perimetry thresholds, dark adaptometry, full field stimulus threshold (FST), photo aversion thresholds (PAT), pupillometry as curves, spectra and topographic maps. ). It is intended to be used by a healthcare professional in a clinical setting.
Who Else Makes It
Registered in Shaanxi. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Vision Monitor – MonCvONE | Listed by | Metrovision SAS, France |
| FDA product code | GWE |
| Device type | Stimulator, Photic, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1890 |
| Establishment | Manufacturer |
| Record published | 2026-07-01 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | manufacturing date, serial number |
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.