FDA Product Code
FDA Product Code GWE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1890
510(k) Clearances — 49 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221471 | E3 and Profile | Diagnosys, LLC | 2022-11-22 | Traditional | PDF ↗ |
| K212936 | Vision Monitor- MonCvONE | Metrovision | 2022-11-21 | Traditional | PDF ↗ |
| K211974 | LED PHOTIC System | Micromed S.P.A. | 2021-09-23 | Traditional | PDF ↗ |
| K211643 | Vision Monitor - MonpackONE | Metrovision | 2021-07-26 | Traditional | PDF ↗ |
| K200705 | Nurochek System | Cryptych Pty, Ltd. | 2020-04-23 | Traditional | PDF ↗ |
| K173936 | Natus Photic Stimulator | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-06-15 | Traditional | PDF ↗ |
| K142567 | RETeval Visual Electrodiagnostic Device | Lkc Technologies, Inc. | 2015-05-19 | Traditional | PDF ↗ |
| K113785 | ADHERENT VISUAL STIMULATOR GOGGLES | Anschel Technology, Inc. | 2012-06-06 | Traditional | PDF ↗ |
| K120104 | VISIONSEARCH 1 | Visionsearch Pty, Ltd. | 2012-05-21 | Traditional | PDF ↗ |
| K101763 | DIOPSYS NOVA VEP VISION TESTING SYSTEM | Diopsys, Inc. | 2011-05-09 | Traditional | PDF ↗ |
| K101691 | LIFELINES PHOTIC STIMULATOR | Lifelines , Ltd. | 2010-08-10 | Traditional | PDF ↗ |
| K081591 | NEUCODIA | Verisci Corporation | 2009-05-15 | Traditional | PDF ↗ |
| K043367 | GLAID OCULAR ELECTROPHYSIOLOGY DEVICE | Lace Electronica S.R.L. | 2005-11-17 | Traditional | PDF ↗ |
| K043491 | ENFANTTM | Diopsys, Inc. | 2005-03-16 | Traditional | PDF ↗ |
| K023525 | RETISCAN, RETIPORT | Roland Consult | 2004-03-26 | Abbreviated | PDF ↗ |
| K022304 | ACCUMAP AUTOMATIC PERIMETER | Objectivision Pty , Ltd. | 2003-11-14 | Traditional | PDF ↗ |
| K011794 | XLTEK LED GOGGLES, MODEL LED-01 | Excel Tech. , Ltd. | 2001-10-01 | Traditional | PDF ↗ |
| K001467 | DA VINCHI EMG/EP ISA1004EP | Airsep Corp. | 2000-08-01 | Traditional | PDF ↗ |
| K991903 | EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) | Excel Tech. , Ltd. | 1999-08-04 | Traditional | PDF ↗ |
| K971214 | KILOWIN | Cadwell Laboratories, Inc. | 1998-06-11 | Traditional | PDF ↗ |
| K932571 | TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 | Tomey Corporation USA | 1995-08-31 | Traditional | PDF ↗ |
| K903734 | ADVANTAGE EP | Clark Davis Medical Systems, Inc. | 1991-07-22 | Traditional | PDF ↗ |
| K883914 | FATIGMETER | K. Jimbo Co., Inc. | 1989-10-31 | Traditional | PDF ↗ |
| K880593 | TECA/MEDELEC MISTRAL | Teca, Inc. | 1988-04-06 | Traditional | PDF ↗ |
| K874136 | PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL | Bio-Logic Systems Corp. | 1988-03-25 | Traditional | PDF ↗ |
| K872725 | MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM | Eyetronics, Inc. | 1987-08-14 | Traditional | PDF ↗ |
| K861069 | TECA NEUROPTO WITH OS-5 STIMULATOR | Teca, Inc. | 1987-01-27 | Traditional | PDF ↗ |
| K860910 | V100 VISUALLY EVOKED POTENTIAL MONITOR | New Potentials, Inc. | 1986-12-18 | Traditional | PDF ↗ |
| K860801 | MODEL 8400 W/MODIFICATIONS (SPECTRUM 32) | Cadwell Laboratories, Inc. | 1986-11-18 | Traditional | PDF ↗ |
| K863956 | MACULOSCOPE(TM) | Doran Instruments, Inc. | 1986-11-13 | Traditional | PDF ↗ |
| K854362 | MODIFIED BRAIN ATLAS III | Bio-Logic Systems Corp. | 1986-04-22 | Traditional | PDF ↗ |
| K852533 | L.E.D. GOGGLES, MODEL 580-LEDGOG | Bio-Logic Systems Corp. | 1985-12-12 | Traditional | PDF ↗ |
| K853412 | WAVE GATE | Wolfline Corp. | 1985-10-28 | Traditional | PDF ↗ |
| K844659 | VPS 2250, CSU2250 & VFU 2250 | Madsen Electronics (Canada) , Ltd. | 1985-02-25 | Traditional | PDF ↗ |
| K844616 | SIEGEN VISUAL STIMULATOR | Siegen Corp. | 1985-02-14 | Traditional | PDF ↗ |
| K842964 | PHOTIC STIMULATOR TM-3030-70 | Tracor Northern, Inc. | 1984-12-28 | Traditional | PDF ↗ |
| K842381 | SLS 3500 LED VISUAL STIMULATOR | Nihon Kohden America, Inc. | 1984-11-09 | Traditional | PDF ↗ |
| K834442 | LED STIMULATOR LS-05 | Teca, Inc. | 1984-08-08 | Traditional | PDF ↗ |
| K831651 | EVOKED POTENTIAL SYSTEM 2000 | Ophthalmetric Corp. | 1983-09-12 | Traditional | PDF ↗ |
| K832084 | EVOKED 3500 POTENTIAL SYSTEM | Tracor Northern, Inc. | 1983-08-16 | Traditional | PDF ↗ |
| K831047 | BIOLOGIC SYSTEM BL 101 | Bio-Logic Systems Corp. | 1983-05-13 | Traditional | PDF ↗ |
| K812061 | MODEL S10VS VISUAL STIMULATOR | Grass Instrument Co. | 1981-08-20 | Traditional | PDF ↗ |
| K810481 | VISUAL PATTERN REVERSAL GEN. & PHOTIC S. | Amplaid USA, Inc. | 1981-03-11 | Traditional | PDF ↗ |
| K801671 | ESG-1 (EVOKED RESPONSE STIMULUS GENER) | Neurodiagnostics, Inc. | 1980-08-04 | Traditional | PDF ↗ |
| K791149 | STIMULATOR MODEL SSS-1101 | Nihon Kohden America, Inc. | 1979-09-17 | Traditional | PDF ↗ |
| K790570 | STIMULATOR, NIC-106 VISUAL | Nicolet Biomedical Instruments | 1979-05-23 | Traditional | PDF ↗ |
| K790217 | GENERATOR, MODEL VG-1 | Street Electronics Corp. | 1979-02-06 | Traditional | PDF ↗ |
| K781461 | MODEL 7320 VISUAL STIMULATOR | Life-Tech Instruments, Inc. | 1978-11-08 | Traditional | PDF ↗ |
| K781398 | TECA VS6 VIDEO STIMULATOR | Teca, Inc. | 1978-08-23 | Traditional | PDF ↗ |
Product code GWE · Class II · Neurology. Data: openFDA.