510(k) K211643

Vision Monitor - MonpackONE by Metrovision — Product Code GWE

K211643 is an FDA 510(k) premarket notification submitted by Metrovision for the device "Vision Monitor - MonpackONE". The FDA issued a decision of Substantially Equivalent on July 26, 2021. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890. Metrovision has at least 1 other 510(k) clearance on record.