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510(k) K212936

Device
Vision Monitor- MonCvONE
Applicant
Metrovision
510(k) number
K212936
Product code
GWE
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-21
Date received
2021-09-15
Regulation
882.1890
Classification name
Stimulator, Photic, Evoked Response
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jacques Charlier
Address
4 Rue Des Platanes Perenchies FR 59840 59840

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GWE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221471E3 and ProfileDiagnosys, LLC2022-11-22
K211974LED PHOTIC SystemMicromed S.P.A.2021-09-23
K211643Vision Monitor - MonpackONEMetrovision2021-07-26
K200705Nurochek SystemCryptych Pty, Ltd.2020-04-23
K173936Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2018-06-15
K142567RETeval Visual Electrodiagnostic DeviceLkc Technologies, Inc.2015-05-19
K113785ADHERENT VISUAL STIMULATOR GOGGLESAnschel Technology, Inc.2012-06-06
K120104VISIONSEARCH 1Visionsearch Pty, Ltd.2012-05-21
K101763DIOPSYS NOVA VEP VISION TESTING SYSTEMDiopsys, Inc.2011-05-09
K101691LIFELINES PHOTIC STIMULATORLifelines , Ltd.2010-08-10
K081591NEUCODIAVerisci Corporation2009-05-15
K043367GLAID OCULAR ELECTROPHYSIOLOGY DEVICELace Electronica S.R.L.2005-11-17
K043491ENFANTTMDiopsys, Inc.2005-03-16
K023525RETISCAN, RETIPORTRoland Consult2004-03-26
K022304ACCUMAP AUTOMATIC PERIMETERObjectivision Pty , Ltd.2003-11-14