The following data is part of a premarket notification filed by Metrovision with the FDA for Vision Monitor - Monpackone.
| Device ID | K211643 |
| 510k Number | K211643 |
| Device Name: | Vision Monitor - MonpackONE |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | Metrovision 4 Rue Des Platanes Perenchies, FR 59840 |
| Contact | Jacques Charlier |
| Correspondent | Jacques Charlier Metrovision 4 Rue Des Platanes Perenchies, FR 59840 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-27 |
| Decision Date | 2021-07-26 |