FDA 510(k) Applications for Medical Device Product Code: GWE (Stimulator, Photic, Evoked Response)

FDA 510(k) Applications for Medical Device Product Code "GWE"
(Stimulator, Photic, Evoked Response)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K001467	AIRSEP CORP.	DA VINCHI EMG/EP ISA1004EP	08/01/2000
K113785	ANSCHEL TECHNOLOGY, INC.	ADHERENT VISUAL STIMULATOR GOGGLES	06/06/2012
K971214	CADWELL LABORATORIES, INC.	KILOWIN	06/11/1998
K200705	Cryptych Pty Ltd	Nurochek System	04/23/2020
K221471	Diagnosys LLC	E3 and Profile	11/22/2022
K101763	DIOPSYS INC.	DIOPSYS NOVA VEP VISION TESTING SYSTEM	05/09/2011
K043491	DIOPSYS INC.	ENFANTTM	03/16/2005
K991903	EXCEL TECH. LTD.	EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)	08/04/1999
K011794	EXCEL TECH. LTD.	XLTEK LED GOGGLES, MODEL LED-01	10/01/2001
K043367	LACE ELECTRONICA S.R.L.	GLAID OCULAR ELECTROPHYSIOLOGY DEVICE	11/17/2005
K101691	LIFELINES LTD.	LIFELINES PHOTIC STIMULATOR	08/10/2010
K142567	LKC Technologies, Inc	RETeval Visual Electrodiagnostic Device	05/19/2015
K211643	Metrovision	Vision Monitor - MonpackONE	07/26/2021
K212936	Metrovision	Vision Monitor- MonCvONE	11/21/2022
K211974	Micromed S.p.A.	LED PHOTIC System	09/23/2021
K173936	Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)	Natus Photic Stimulator	06/15/2018
K022304	OBJECTIVISION PTY LTD.	ACCUMAP AUTOMATIC PERIMETER	11/14/2003
K023525	ROLAND CONSULT	RETISCAN, RETIPORT	03/26/2004
K081591	VERISCI CORPORATION	NEUCODIA	05/15/2009
K120104	VISIONSEARCH PTY LTD	VISIONSEARCH 1	05/21/2012