Stimulator, Photic, Evoked Response
Regulation 882.1890
0510(k)s in 12 months (49 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in GWE
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio-Logic Systems Corp. | 4 | 0 |
| Diopsys, Inc. | 2 | 2 |
| Teca, Inc. | 4 | 0 |
| Cadwell Laboratories, Inc. | 2 | 0 |
| Excel Tech. , Ltd. | 2 | 0 |
| Metrovision | 2 | 0 |
| Nihon Kohden America, Inc. | 2 | 0 |
| Tracor Northern, Inc. | 2 | 0 |
| Airsep Corp. | 1 | 0 |
| Amplaid USA, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 22, 2022 | K221471 | E3 and Profile Diagnosys, LLC | GWE |
| Nov 21, 2022 | K212936 | Vision Monitor- MonCvONE Metrovision, FR | GWE |
| Sep 23, 2021 | K211974 | LED PHOTIC System Micromed S.P.A., IT | GWE |
| Jul 26, 2021 | K211643 | Vision Monitor - MonpackONE Metrovision, FR | GWE |
| Apr 23, 2020 | K200705 | Nurochek System Cryptych Pty, Ltd., AU | GWE |
| Jun 15, 2018 | K173936 | Natus Photic Stimulator Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | GWE |
| May 19, 2015 | K142567 | RETeval Visual Electrodiagnostic Device Lkc Technologies, Inc. | GWE |
| Jun 6, 2012 | K113785 | ADHERENT VISUAL STIMULATOR GOGGLES Anschel Technology, Inc. | GWE |
| May 21, 2012 | K120104 | VISIONSEARCH 1 Visionsearch Pty, Ltd., AU | GWE |
| May 9, 2011 | K101763 | DIOPSYS NOVA VEP VISION TESTING SYSTEM Diopsys, Inc. | GWE |
| Aug 10, 2010 | K101691 | LIFELINES PHOTIC STIMULATOR Lifelines , Ltd. | GWE |
| May 15, 2009 | K081591 | NEUCODIA Verisci Corporation | GWE |
| Nov 17, 2005 | K043367 | GLAID OCULAR ELECTROPHYSIOLOGY DEVICE Lace Electronica S.R.L. | GWE |
| Mar 16, 2005 | K043491 | ENFANTTM Diopsys, Inc. | GWE |
| Mar 26, 2004 | K023525 | RETISCAN, RETIPORT Roland Consult, DE | GWE |
| Nov 14, 2003 | K022304 | ACCUMAP AUTOMATIC PERIMETER Objectivision Pty , Ltd. | GWE |
| Oct 1, 2001 | K011794 | XLTEK LED GOGGLES, MODEL LED-01 Excel Tech. , Ltd., CA | GWE |
| Aug 1, 2000 | K001467 | DA VINCHI EMG/EP ISA1004EP Airsep Corp. | GWE |
| Aug 4, 1999 | K991903 | EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) Excel Tech. , Ltd., CA | GWE |
| Jun 11, 1998 | K971214 | KILOWIN Cadwell Laboratories, Inc. | GWE |
| Aug 31, 1995 | K932571 | TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 Tomey Corporation USA | GWE |
| Jul 22, 1991 | K903734 | ADVANTAGE EP Clark Davis Medical Systems, Inc., CA | GWE |
| Oct 31, 1989 | K883914 | FATIGMETER K. Jimbo Co., Inc. | GWE |
| Apr 6, 1988 | K880593 | TECA/MEDELEC MISTRAL Teca, Inc. | GWE |
| Mar 25, 1988 | K874136 | PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL Bio-Logic Systems Corp. | GWE |
| Aug 14, 1987 | K872725 | MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM Eyetronics, Inc. | GWE |
| Jan 27, 1987 | K861069 | TECA NEUROPTO WITH OS-5 STIMULATOR Teca, Inc. | GWE |
| Dec 18, 1986 | K860910 | V100 VISUALLY EVOKED POTENTIAL MONITOR New Potentials, Inc. | GWE |
| Nov 18, 1986 | K860801 | MODEL 8400 W/MODIFICATIONS (SPECTRUM 32) Cadwell Laboratories, Inc. | GWE |
| Nov 13, 1986 | K863956 | MACULOSCOPE(TM) Doran Instruments, Inc. | GWE |
| Apr 22, 1986 | K854362 | MODIFIED BRAIN ATLAS III Bio-Logic Systems Corp. | GWE |
| Dec 12, 1985 | K852533 | L.E.D. GOGGLES, MODEL 580-LEDGOG Bio-Logic Systems Corp. | GWE |
| Oct 28, 1985 | K853412 | WAVE GATE Wolfline Corp. | GWE |
| Feb 25, 1985 | K844659 | VPS 2250, CSU2250 & VFU 2250 Madsen Electronics (Canada) , Ltd., CA | GWE |
| Feb 14, 1985 | K844616 | SIEGEN VISUAL STIMULATOR Siegen Corp. | GWE |
| Dec 28, 1984 | K842964 | PHOTIC STIMULATOR TM-3030-70 Tracor Northern, Inc. | GWE |
| Nov 9, 1984 | K842381 | SLS 3500 LED VISUAL STIMULATOR Nihon Kohden America, Inc. | GWE |
| Aug 8, 1984 | K834442 | LED STIMULATOR LS-05 Teca, Inc. | GWE |
| Sep 12, 1983 | K831651 | EVOKED POTENTIAL SYSTEM 2000 Ophthalmetric Corp. | GWE |
| Aug 16, 1983 | K832084 | EVOKED 3500 POTENTIAL SYSTEM Tracor Northern, Inc. | GWE |
| May 13, 1983 | K831047 | BIOLOGIC SYSTEM BL 101 Bio-Logic Systems Corp. | GWE |
| Aug 20, 1981 | K812061 | MODEL S10VS VISUAL STIMULATOR Grass Instrument Co. | GWE |
| Mar 11, 1981 | K810481 | VISUAL PATTERN REVERSAL GEN. & PHOTIC S. Amplaid USA, Inc. | GWE |
| Aug 4, 1980 | K801671 | ESG-1 (EVOKED RESPONSE STIMULUS GENER) Neurodiagnostics, Inc. | GWE |
| Sep 17, 1979 | K791149 | STIMULATOR MODEL SSS-1101 Nihon Kohden America, Inc. | GWE |
| May 23, 1979 | K790570 | STIMULATOR, NIC-106 VISUAL Nicolet Biomedical Instruments | GWE |
| Feb 6, 1979 | K790217 | GENERATOR, MODEL VG-1 Street Electronics Corp. | GWE |
| Nov 8, 1978 | K781461 | MODEL 7320 VISUAL STIMULATOR Life-Tech Instruments, Inc. | GWE |
| Aug 23, 1978 | K781398 | TECA VS6 VIDEO STIMULATOR Teca, Inc. | GWE |
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