K211643 is an FDA 510(k) clearance for the Vision Monitor - MonpackONE. This device is classified as a Stimulator, Photic, Evoked Response (Class II - Special Controls, product code GWE).
Submitted by Metrovision (Perenchies, FR). The FDA issued a Cleared decision on July 26, 2021, 60 days after receiving the submission on May 27, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 882.1890.
| 510(k) Number | K211643 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 2021 |
| Decision Date | July 26, 2021 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | GWE - Stimulator, Photic, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1890 |