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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
Predetermined Change
Control Plan Authorized		 No
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