Cleared Traditional

Vision Monitor - MonpackONE

K211643 · Metrovision · Ophthalmic

Jul 2021

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K211643 is an FDA 510(k) clearance for the Vision Monitor - MonpackONE, 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 review panel. Regulated under 21 CFR 882.1890.

Submission Details

510(k) Number	K211643 FDA.gov
FDA Decision	Cleared 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