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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Photic, Evoked Response
510(k) Number K212936
Device Name Vision Monitor- MonCvONE
Applicant
Metrovision
4 rue des Platanes
Perenchies,  FR 59840
Applicant Contact Jacques Charlier
Correspondent
Metrovision
4 rue des Platanes
Perenchies,  FR 59840
Correspondent Contact Jacques Charlier
Regulation Number882.1890
Classification Product Code
GWE  
Subsequent Product Code
HLT  
Date Received09/15/2021
Decision Date 11/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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