Product code GWE
- Device name
- Stimulator, Photic, Evoked Response
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1890
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221471 | E3 and Profile | Diagnosys, LLC | 2022-11-22 |
| K212936 | Vision Monitor- MonCvONE | Metrovision | 2022-11-21 |
| K211974 | LED PHOTIC System | Micromed S.P.A. | 2021-09-23 |
| K211643 | Vision Monitor - MonpackONE | Metrovision | 2021-07-26 |
| K200705 | Nurochek System | Cryptych Pty, Ltd. | 2020-04-23 |
| K173936 | Natus Photic Stimulator | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-06-15 |
| K142567 | RETeval Visual Electrodiagnostic Device | Lkc Technologies, Inc. | 2015-05-19 |
| K113785 | ADHERENT VISUAL STIMULATOR GOGGLES | Anschel Technology, Inc. | 2012-06-06 |
| K120104 | VISIONSEARCH 1 | Visionsearch Pty, Ltd. | 2012-05-21 |
| K101763 | DIOPSYS NOVA VEP VISION TESTING SYSTEM | Diopsys, Inc. | 2011-05-09 |
| K101691 | LIFELINES PHOTIC STIMULATOR | Lifelines , Ltd. | 2010-08-10 |
| K081591 | NEUCODIA | Verisci Corporation | 2009-05-15 |
| K043367 | GLAID OCULAR ELECTROPHYSIOLOGY DEVICE | Lace Electronica S.R.L. | 2005-11-17 |
| K043491 | ENFANTTM | Diopsys, Inc. | 2005-03-16 |
| K023525 | RETISCAN, RETIPORT | Roland Consult | 2004-03-26 |
| K022304 | ACCUMAP AUTOMATIC PERIMETER | Objectivision Pty , Ltd. | 2003-11-14 |
| K011794 | XLTEK LED GOGGLES, MODEL LED-01 | Excel Tech. , Ltd. | 2001-10-01 |
| K001467 | DA VINCHI EMG/EP ISA1004EP | Airsep Corp. | 2000-08-01 |
| K991903 | EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) | Excel Tech. , Ltd. | 1999-08-04 |
| K971214 | KILOWIN | Cadwell Laboratories, Inc. | 1998-06-11 |
| K932571 | TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 | Tomey Corporation USA | 1995-08-31 |
| K903734 | ADVANTAGE EP | Clark Davis Medical Systems, Inc. | 1991-07-22 |
| K883914 | FATIGMETER | K. Jimbo Co., Inc. | 1989-10-31 |
| K880593 | TECA/MEDELEC MISTRAL | Teca, Inc. | 1988-04-06 |
| K874136 | PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL | Bio-Logic Systems Corp. | 1988-03-25 |
| K872725 | MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM | Eyetronics, Inc. | 1987-08-14 |
| K861069 | TECA NEUROPTO WITH OS-5 STIMULATOR | Teca, Inc. | 1987-01-27 |
| K860910 | V100 VISUALLY EVOKED POTENTIAL MONITOR | New Potentials, Inc. | 1986-12-18 |
| K860801 | MODEL 8400 W/MODIFICATIONS (SPECTRUM 32) | Cadwell Laboratories, Inc. | 1986-11-18 |
| K863956 | MACULOSCOPE(TM) | Doran Instruments, Inc. | 1986-11-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08056446900338 | NeMus 2 600 | EB NEURO SPA | 2025-05-26 |
| 08056446900345 | NeMus 2 700 | EB NEURO SPA | 2025-05-26 |
| 08056446900352 | NeMus 2 + | EB NEURO SPA | 2025-05-26 |
| 08056446901205 | NExT Station | EB NEURO SPA | 2025-05-22 |
| 08056446901038 | GOGGLES STIMULATOR II | EB NEURO SPA | 2025-05-22 |
| 08056446901106 | NExT-DOCKING | EB NEURO SPA | 2025-05-22 |
| 08056446901113 | NExT-PAD | EB NEURO SPA | 2025-05-22 |
| 08056446901120 | NExT-AMP-ADVANCED | EB NEURO SPA | 2025-05-22 |
| 08056446901137 | NExT-HS | EB NEURO SPA | 2025-05-22 |
| 08056446901168 | NExT-AMP | EB NEURO SPA | 2025-05-22 |
| 08056446901199 | NExT-AS | EB NEURO SPA | 2025-05-22 |
| 08056446901090 | NExT Station Advanced | EB NEURO SPA | 2025-05-19 |
| 08056446900642 | Galileo NT Line Software | EB NEURO SPA | 2020-05-25 |
| 08056446900369 | NeMus 2 | EB NEURO SPA | 2019-04-10 |
| 08056446900376 | NeMus 2 | EB NEURO SPA | 2019-04-10 |
| 08033928120958 | Micromed | MICROMED SPA | 2018-05-21 |
| 08033928120880 | micromed | MICROMED SPA | 2018-03-21 |
| 10850514007036 | Diopsys® | DIOPSYS, INC. | 2017-03-27 |
| 10850514007050 | Diopsys® | DIOPSYS, INC. | 2017-03-27 |
| 20613994327820 | N/A | MEDTRONIC XOMED, INC. | 2016-07-01 |
| 20613994330059 | N/A | MEDTRONIC SOFAMOR DANEK, INC. | 2016-07-01 |
| 20613994802372 | NA | MEDTRONIC XOMED, INC. | 2016-05-13 |
| 20613994801528 | NA | MEDTRONIC XOMED, INC. | 2016-05-01 |
| 20613994802266 | NA | MEDTRONIC XOMED, INC. | 2016-05-01 |
| 20613994801405 | NA | MEDTRONIC XOMED, INC. | 2016-04-30 |
| 20613994801511 | NA | MEDTRONIC XOMED, INC. | 2016-04-30 |
| 20613994801535 | NA | MEDTRONIC XOMED, INC. | 2016-04-30 |
| 20613994802259 | NA | MEDTRONIC XOMED, INC. | 2016-04-30 |
| 20613994802273 | NA | MEDTRONIC XOMED, INC. | 2016-04-30 |
| 20613994802358 | NA | MEDTRONIC XOMED, INC. | 2016-04-30 |