Stimulator, Photic, Evoked Response

FDA product code GWE · 48 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.1890
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1978-08-23 – 2022-11-22

GWE 2022-11-22

E3 and Profile

Applicant Diagnosys, LLC

K number K221471

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GWE 2022-11-21

Vision Monitor- MonCvONE

Applicant Metrovision

K number K212936

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GWE 2021-09-23

LED PHOTIC System

Applicant Micromed S.P.A.

K number K211974

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GWE 2021-07-26

Vision Monitor - MonpackONE

Applicant Metrovision

K number K211643

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GWE 2020-04-23

Nurochek System

Applicant Cryptych Pty, Ltd.

K number K200705

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GWE 2018-06-15

Natus Photic Stimulator

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K number K173936

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GWE 2012-06-06

ADHERENT VISUAL STIMULATOR GOGGLES

Applicant Anschel Technology, Inc.

K number K113785

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GWE 2012-05-21

VISIONSEARCH 1

Applicant Visionsearch Pty, Ltd.

K number K120104

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GWE 2011-05-09

DIOPSYS NOVA VEP VISION TESTING SYSTEM

Applicant Diopsys, Inc.

K number K101763

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GWE 2010-08-10

LIFELINES PHOTIC STIMULATOR

Applicant Lifelines , Ltd.

K number K101691

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GWE 2009-05-15

NEUCODIA

Applicant Verisci Corporation

K number K081591

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GWE 2005-11-17

GLAID OCULAR ELECTROPHYSIOLOGY DEVICE

Applicant Lace Electronica S.R.L.

K number K043367

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GWE 2005-03-16

ENFANTTM

Applicant Diopsys, Inc.

K number K043491

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GWE 2004-03-26

RETISCAN, RETIPORT

Applicant Roland Consult

K number K023525

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GWE 2003-11-14

ACCUMAP AUTOMATIC PERIMETER

Applicant Objectivision Pty , Ltd.

K number K022304

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GWE 2001-10-01

XLTEK LED GOGGLES, MODEL LED-01

Applicant Excel Tech. , Ltd.

K number K011794

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GWE 2000-08-01

DA VINCHI EMG/EP ISA1004EP

Applicant Airsep Corp.

K number K001467

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GWE 1999-08-04

EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)

Applicant Excel Tech. , Ltd.

K number K991903

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GWE 1998-06-11

KILOWIN

Applicant Cadwell Laboratories, Inc.

K number K971214

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GWE 1995-08-31

TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4

Applicant Tomey Corporation USA

K number K932571

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GWE 1991-07-22

ADVANTAGE EP

Applicant Clark Davis Medical Systems, Inc.

K number K903734

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GWE 1989-10-31

FATIGMETER

Applicant K. Jimbo Co., Inc.

K number K883914

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GWE 1988-04-06

TECA/MEDELEC MISTRAL

Applicant Teca, Inc.

K number K880593

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GWE 1988-03-25

PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL

Applicant Bio-Logic Systems Corp.

K number K874136

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GWE 1987-08-14

MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM

Applicant Eyetronics, Inc.

K number K872725

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GWE 1987-01-27

TECA NEUROPTO WITH OS-5 STIMULATOR

Applicant Teca, Inc.

K number K861069

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GWE 1986-12-18

V100 VISUALLY EVOKED POTENTIAL MONITOR

Applicant New Potentials, Inc.

K number K860910

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GWE 1986-11-18

MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)

Applicant Cadwell Laboratories, Inc.

K number K860801

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GWE 1986-11-13

MACULOSCOPE(TM)

Applicant Doran Instruments, Inc.

K number K863956

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GWE 1986-04-22

MODIFIED BRAIN ATLAS III

Applicant Bio-Logic Systems Corp.

K number K854362

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GWE 1985-12-12

L.E.D. GOGGLES, MODEL 580-LEDGOG

Applicant Bio-Logic Systems Corp.

K number K852533

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GWE 1985-10-28

WAVE GATE

Applicant Wolfline Corp.

K number K853412

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GWE 1985-02-25

VPS 2250, CSU2250 & VFU 2250

Applicant Madsen Electronics (Canada) , Ltd.

K number K844659

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GWE 1985-02-14

SIEGEN VISUAL STIMULATOR

Applicant Siegen Corp.

K number K844616

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GWE 1984-12-28

PHOTIC STIMULATOR TM-3030-70

Applicant Tracor Northern, Inc.

K number K842964

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GWE 1984-11-09

SLS 3500 LED VISUAL STIMULATOR

Applicant Nihon Kohden America, Inc.

K number K842381

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GWE 1984-08-08

LED STIMULATOR LS-05

Applicant Teca, Inc.

K number K834442

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GWE 1983-09-12

EVOKED POTENTIAL SYSTEM 2000

Applicant Ophthalmetric Corp.

K number K831651

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GWE 1983-08-16

EVOKED 3500 POTENTIAL SYSTEM

Applicant Tracor Northern, Inc.

K number K832084

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GWE 1983-05-13

BIOLOGIC SYSTEM BL 101

Applicant Bio-Logic Systems Corp.

K number K831047

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GWE 1981-08-20

MODEL S10VS VISUAL STIMULATOR

Applicant Grass Instrument Co.

K number K812061

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GWE 1981-03-11

VISUAL PATTERN REVERSAL GEN. & PHOTIC S.

Applicant Amplaid USA, Inc.

K number K810481

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GWE 1980-08-04

ESG-1 (EVOKED RESPONSE STIMULUS GENER)

Applicant Neurodiagnostics, Inc.

K number K801671

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GWE 1979-09-17

STIMULATOR MODEL SSS-1101

Applicant Nihon Kohden America, Inc.

K number K791149

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GWE 1979-05-23

STIMULATOR, NIC-106 VISUAL

Applicant Nicolet Biomedical Instruments

K number K790570

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GWE 1979-02-06

GENERATOR, MODEL VG-1

Applicant Street Electronics Corp.

K number K790217

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GWE 1978-11-08

MODEL 7320 VISUAL STIMULATOR

Applicant Life-Tech Instruments, Inc.

K number K781461

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GWE 1978-08-23

TECA VS6 VIDEO STIMULATOR

Applicant Teca, Inc.

K number K781398

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