Data / Medical devices / France / Metrovision SAS
Metrovision SAS: FDA-registered device maker in Perenchies Nord, France, 2 510(k) clearances
Metrovision SAS is registered with the FDA (registration 3008058195) in Perenchies Nord, France. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 21, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008058195
- Address
- 4 rue des Platanes, Perenchies Nord, France, 59840
- Owner or operator
- Metrovision SAS (10030671)
- Roles
- Manufacturer
- First device listed
- October 29, 2009
- Registered through
- 2026
- Brand names listed
- MonCv3, MonCv3, MonCvONE, MonCvONE, MonPackONE, Vision Monitor MonCvONE, Vision Monitor MonPAckONE, Vision Monitor MonColor, Vision Monitor MonCv3 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation | OUM | 1 | Manufacturer | accessdata.fda.gov |
| Chart, Visual Acuity | HOX | 1 | Manufacturer | accessdata.fda.gov |
| Perimeter, Automatic, Ac-Powered | HPT | 1 | Manufacturer | accessdata.fda.gov |
| Preamplifier, Ac-Powered, Ophthalmic | HLT | 2 | Manufacturer | accessdata.fda.gov |
| Pupillometer, Ac-Powered | HLG | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Photic, Evoked Response | GWE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 21, 2022 | K212936 | Vision Monitor- MonCvONE | GWE | Substantially Equivalent | Metrovision | accessdata.fda.gov |
| July 26, 2021 | K211643 | Vision Monitor - MonpackONE | GWE | Substantially Equivalent | Metrovision | accessdata.fda.gov |
Compare with other makers
- All makers of Pupillometer, Ac-Powered
- All makers of Stimulator, Photic, Evoked Response
- All makers of Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation
- All makers of Perimeter, Automatic, Ac-Powered
- All makers of Chart, Visual Acuity
Updated November 21, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.