The Vision Monitor MonPackONE system is a non invasive electrodiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and…
The Vision Monitor MonPackONE system is a non invasive electrodiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG), visual evoked potential (VEP) and sensory electro-oculogram (EOG) signals. It can also perform central visual field, pupillometry, dark adaptometry and display optotypes for visual acuity tests. ). 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 – MonPackONE | 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.