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

FDA 510(k) Number Applicant Device Name Decision Date
K000963 AIRSEP CORP. DA VINCHI EEG AND EMG/EP SYSTEMS 10/20/2000
K213849 Alphatec Spine, Inc. SafeOp 2: Neural Informatix System 03/09/2022
K971740 AMPLIFON S.P.A. AMPLAID MK12 03/16/1998
K972959 AMPLIFON S.P.A. AMPLAID MK22 02/06/1998
K050798 AXON SYSTEMS, INC. ECLIPSE NEUROLOGICAL WORKSTATION 08/15/2005
K061639 AXON SYSTEMS, INC. ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON 11/01/2006
K971819 AXON SYSTEMS, INC. EPOCH 2000 NEUROLOGICAL WORKSTATION 11/20/1997
K032741 AXON SYSTEMS, INC. EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION 12/16/2003
K061113 AXON SYSTEMS, INC. ORTHOMON 05/23/2006
K955257 AXON SYSTEMS, INC. SS102 DUAL CHANNEL SEP STIMULATOR 02/02/1996
K963662 BIOSOUND, INC. GALILEO EVOKED POTENTIALRE 02/26/1997
K230415 Cadwell Industries, Inc. Cadwell Guardian 08/17/2023
K162199 CADWELL INDUSTRIES, INC. Cascade IOMAX Intraoperative Monitor 03/02/2017
K962458 CADWELL LABORATORIES, INC. CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER 01/13/1997
K962455 CADWELL LABORATORIES, INC. FOUR-CHANNEL PREAMPLIFIER 01/13/1997
K042350 CADWELL LABORATORIES, INC. TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR 11/03/2004
K962457 CADWELL LABORATORIES, INC. TWO-CHANNEL PREAMPLIFIER 01/13/1997
K112052 CAREFUSION 209, INC. CAREFUSION NICOLET EDX 03/15/2012
K120979 CAREFUSION 209, INC. CAREFUSION NICOLET EDX 04/25/2012
K952294 COMPUTATIONAL DIAGNOSTICS, INC. NEURONET 01/26/1996
K051357 DIGITIMER LTD. DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH 09/20/2005
K150220 EB NEURO, S.P.A. STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast 08/19/2015
K992313 EXCEL TECH. LTD. XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16 08/19/1999
K001101 EXCEL TECH. LTD. XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 06/30/2000
K010090 EXCEL TECH. LTD. XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) 03/26/2001
K010092 EXCEL TECH. LTD. XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED) 04/02/2001
K040358 EXCEL TECH. LTD. XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 08/06/2004
K010087 EXCEL TECH. LTD. XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP 03/19/2001
K111647 INOMED MEDIZINTECHNIK GMBH C2 NERVEMONITOR SYSTEM WITH ACCESSORIES 10/06/2011
K212166 inomed Medizintechnik GmbH ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress 01/07/2022
K082614 LABORIE MEDICAL TECHNOLOGIES, INC. EVOX ELECTRO DIAGNOSTIC DEVICE 03/06/2009
K060847 MAGSTIM COMPANY US, LLC. MAGSTIM 200-2 09/26/2006
K992911 MAGSTIM CORPORATION US MAGSTIM RAPID 01/07/2000
K965065 MEDELEC LTD. TECA. MILLENNIUM 06/20/1997
K031930 MEDICAL MEASUREMENT SYSTEMS,B.V. HIGH SPEED EMG MODULE 03/03/2004
K083124 MEDTRONIC XOMED, INC. NIM 3.0 02/27/2009
K200759 Medtronic Xomed, Inc. NIM Vital, Nerve Integrity Monitor 10/28/2020
K020400 MEPS, LLC. DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR 08/23/2002
K960170 MOBERG MEDICAL, INC. ELECTROENCEPHALOGRAPH (EEG) 03/01/1996
K083371 NATUS MEDICAL, INC. NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) 12/08/2009
K093304 NATUS MEDICAL, INC. PROTEKTOR 32 08/11/2010
K130346 NATUS NEUROLOGY INCORPORATED SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION 05/02/2013
K980866 NEURO-DIAGNOSTIC ASSOC. MEDI-DX 7000 CPT WITH AMREX ELECTRODES 05/20/1998
K932994 NEUROMEDICAL SYSTEMS, INC. EVOKED POTENTIAL SYSTEM-1.0 04/15/1996
K190703 Neurosoft Ltd Neuro-IOM system with Neuro-IOM.NET software 05/22/2021
K170677 Neurovision Medical Product Inc. Neurovision Nerve Locator Monitor (Nerveana), EMGView Software 04/05/2017
K110140 NEUROVISION MEDICAL PRODUCTS, INC. NEUROVISION NERVE LOCATOR MONITOR 09/30/2011
K091457 NEXSTIM OY NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM 12/08/2009
K112881 NEXSTIM OY NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) 05/22/2012
K051178 NIHON KOHDEN AMERICA, INC. MEE-1000A NEUROMASTER 08/17/2005
K991899 NIHON KOHDEN AMERICA, INC. NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES 09/01/1999
K071969 NIHON KOHDEN AMERICA, INC. SEN-4100 ELECTRIC STIMULATOR 10/06/2008
K120397 NIHON KOHDEN CORP. MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM 09/19/2012
K142624 Nihon Kohden Corporation Neuromaster G1 MEE200 04/24/2015
K094054 NUVASIVE, INC. MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE 05/14/2010
K062765 NUVASIVE, INC. MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM 01/24/2007
K051384 NUVASIVE, INC. MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM 07/11/2005
K072343 NUVASIVE, INC. NEUROVISION JJB SYSTEM 10/29/2007
K090298 NUVASIVE, INC. NUVASIVE NEURO VISION SYSTEM 06/08/2009
K981405 OXFORD INSTRUMENTS, PLC. SYNERGY LT 07/16/1998
K002773 RADIONICS, INC. NEUROMAP WITH NEURO 100 10/23/2000
K132616 SAFEOP SURGICAL, INC. EPAD 01/24/2014
K182542 SafeOp Surgical, Inc. The EPAD 2 System 02/22/2019
K192823 Soterix Medical, Inc. MEGA-TMS 08/13/2021
K030526 SPINEVISION, INC. PEDIGUARD NERVE DETECTOR SYSTEM 12/29/2004
K123843 STROHL MEDICAL TECHNOLOGIES NEUROEPG SYSTEM 06/05/2013
K130403 THE MAGSTIM COMPANY LTD. MAGSTIM DOUBLE 70-2 COIL 08/23/2013
K080499 THE MAGSTIM COMPANY LTD. MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 12/08/2008
K051864 THE MAGSTIM COMPANY LTD. MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 12/21/2005
K071821 TONICA ELEKTRONIK A/S COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65 07/27/2007
K160280 TONICA ELEKTRONIK A/S MagPro R20 05/16/2016
K061645 TONICA ELEKTRONIK A/S MAGPRO, MODEL R30 10/31/2006
K091940 TONICA ELEKTRONIK A/S MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION 03/26/2010
K162873 TONICA ELEKTRONIK A/S MEP Monitor 03/31/2017
K002969 XLTEK XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 12/08/2000


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