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 |