Cleared Traditional

Vision Monitor- MonCvONE

K212936 · Metrovision · Ophthalmic
Nov 2022
Decision
432d
Days
Class 2
Risk

About This 510(k) Submission

K212936 is an FDA 510(k) clearance for the Vision Monitor- MonCvONE, a Stimulator, Photic, Evoked Response (Class II — Special Controls, product code GWE), submitted by Metrovision (Perenchies, FR). The FDA issued a Cleared decision on November 21, 2022, 432 days after receiving the submission on September 15, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 882.1890.

Submission Details

510(k) Number K212936 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2021
Decision Date November 21, 2022
Days to Decision 432 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code GWE — Stimulator, Photic, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1890