ClearanceBrief
Panels › Neurology › Product code GWF · Class 2

Stimulator, Electrical, Evoked Response

Regulation 882.1870

3510(k)s in 12 months (141 all time)
2recalls in 12 months (17 all time)
17recalls that name a 510(k)
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Top companies in GWF

Decided510(k)Device and applicantCode
Sep 20, 2005K051357DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH
Digitimer , Ltd.
GWF
Aug 17, 2005K051178MEE-1000A NEUROMASTER
Nihon Kohden America, Inc.
GWF
Aug 15, 2005K050798ECLIPSE NEUROLOGICAL WORKSTATION
Axon Systems, Inc.
GWF
Jul 11, 2005K051384MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
Nuvasive, Inc.
GWF
Dec 29, 2004K030526PEDIGUARD NERVE DETECTOR SYSTEM
Spine Vision, Inc.
GWF
Nov 3, 2004K042350TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
Cadwell Laboratories, Inc.
GWF
Aug 6, 2004K040358XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
Excel Tech. , Ltd., CA
GWF
Mar 3, 2004K031930HIGH SPEED EMG MODULE
Medical Measurement Systems B.V., NL
GWF
Dec 16, 2003K032741EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION
Axon Systems, Inc.
GWF
Aug 23, 2002K020400DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR
Meps, LLC
GWF
Apr 2, 2001K010092XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
Excel Tech. , Ltd., CA
GWF
Mar 26, 2001K010090XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)
Excel Tech. , Ltd., CA
GWF
Mar 19, 2001K010087XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
Excel Tech. , Ltd., CA
GWF
Dec 8, 2000K002969XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
Xltek, CA
GWF
Oct 23, 2000K002773NEUROMAP WITH NEURO 100
Radionics, Inc.
GWF
Oct 20, 2000K000963DA VINCHI EEG AND EMG/EP SYSTEMS
Airsep Corp.
GWF
Jun 30, 2000K001101XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4
Excel Tech. , Ltd., CA
GWF
Jan 7, 2000K992911MAGSTIM RAPID
Magstim Corporation US
GWF
Sep 1, 1999K991899NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES
Nihon Kohden America, Inc.
GWF
Aug 19, 1999K992313XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
Excel Tech. , Ltd., CA
GWF
Jul 16, 1998K981405SYNERGY LT
Oxford Instruments, Plc., GB
GWF
May 20, 1998K980866MEDI-DX 7000 CPT WITH AMREX ELECTRODES
Neuro-Diagnostic Assoc.
GWF
Mar 16, 1998K971740AMPLAID MK12
Amplifon S.P.A.
GWF
Feb 6, 1998K972959AMPLAID MK22
Amplifon S.P.A.
GWF
Nov 20, 1997K971819EPOCH 2000 NEUROLOGICAL WORKSTATION
Axon Systems, Inc.
GWF
Jun 20, 1997K965065TECA. MILLENNIUM
Medelec , Ltd., GB
GWF
Feb 26, 1997K963662GALILEO EVOKED POTENTIALRE
Biosound, Inc.
GWF
Jan 13, 1997K962458CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER
Cadwell Laboratories, Inc.
GWF
Jan 13, 1997K962457TWO-CHANNEL PREAMPLIFIER
Cadwell Laboratories, Inc.
GWF
Jan 13, 1997K962455FOUR-CHANNEL PREAMPLIFIER
Cadwell Laboratories, Inc.
GWF
Apr 15, 1996K932994EVOKED POTENTIAL SYSTEM-1.0
Neuromedical Systems, Inc.
GWF
Mar 1, 1996K960170ELECTROENCEPHALOGRAPH (EEG)
Moberg Medical, Inc.
GWF
Feb 2, 1996K955257SS102 DUAL CHANNEL SEP STIMULATOR
Axon Systems, Inc.
GWF
Jan 26, 1996K952294NEURONET
Computational Diagnostics, Inc.
GWF
Sep 19, 1995K944547DANTEC KEYPOINT
Mckenna & Cuneo
GWF
May 10, 1995K950208NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM
Nihon Kohden America, Inc.
GWF
Nov 9, 1993K931923DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE)
Dantec Medical, Inc.
GWF
Aug 31, 1993K926516DANTEC MAGNETIC STIMULATOR MAGPRO
Dantec Medical, Inc.
GWF
Jun 22, 1993K931428CADWELL 6200 A
Cadwell Laboratories, Inc.
GWF
Mar 23, 1993K924723CADWELL SIERRA
Cadwell Laboratories, Inc.
GWF
Mar 10, 1993K924127DANTEC EVOLUTION
Dantec Medical, Inc.
GWF
Nov 24, 1992K923303SAPPHIRE PREMIERE
Medelec , Ltd., GB
GWF
Nov 23, 1992K923315NICOLET ARK SYSTEM
Nicolet Instrument Corp.
GWF
Feb 26, 1992K912685MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
Nihon Kohden America, Inc.
GWF
Feb 7, 1992K915652NICOLET PORATBLE SPIRIT SYSTEM
Nicolet Instrument Corp.
GWF
Nov 8, 1991K912775SAPPHIRE 4ME EMG/EP SYSTEM
Medelec Intl. Corp., GB
GWF
Sep 18, 1991K905059HIGH SPEED MAGNETIC STIMULATOR
Cadwell Laboratories, Inc.
GWF
May 14, 1991K902607DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2)
Dantec Medical, Inc.
GWF
Feb 4, 1991K903731SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME
Teca, Inc.
GWF
Aug 8, 1990K894560QSI 9000
Quantified Signal Imaging, Inc., CA
GWF

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