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 |
| K234092 | Alphatec Spine, Inc. | SafeOp 3: Neural Informatix Systeem | 04/19/2024 |
| 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 |
| K233292 | inomed Medizintechnik GmbH | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | 10/27/2023 |
| 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 |
| K243495 | Natus Neurology Incorporated | Natus Ultrapro S100 (982A0594) | 12/12/2024 |
| K243982 | Natus Neurology Incorporated | Nicolet EDX | 01/22/2025 |
| 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 |
| K242345 | QuantalX Neuroscience | Delphi Stimulator | 11/05/2024 |
| 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 |
| K234080 | Soterix Medical, Inc. | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | 03/25/2024 |
| 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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
