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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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NA - 04931921112991

EEG trend program
NIHON KOHDEN CORPORATION
QP-160AK
In Commercial Distribution

  • 04931921112991 ()
QP-160AK

  • Electroencephalograph

NA - 04931921112946

Photic stimulator control unit
NIHON KOHDEN CORPORATION
LS-120AJ
In Commercial Distribution

  • 04931921112946 ()
LS-120AJ

  • Electroencephalograph

NA - 04931921112885

CART, COMPACT TYPE, EEG-1200A
NIHON KOHDEN CORPORATION
KE-122A
In Commercial Distribution

  • 04931921112885 ()
KE-122A

  • Instrument trolley

NA - 04931921112724

ADAPTER DUAL MOUNT, PHOTIC / INPUT
NIHON KOHDEN CORPORATION
DI-120A
In Commercial Distribution

  • 04931921112724 ()
DI-120A

  • Instrument trolley

Neurofax - 04931921110904

Neurofax Electroencephalograph
NIHON KOHDEN CORPORATION
EEG-1200A
In Commercial Distribution

  • 04931921110904 ()
EEG-1200A

  • Electroencephalograph

NA - 04931921104170

Input box converter, EEG-1200A
NIHON KOHDEN CORPORATION
QI-122A
In Commercial Distribution

  • 04931921104170 ()
QI-122A

  • Electroencephalograph

Neurofax - 04931921009161

Neurofax Electroencephalograph
NIHON KOHDEN CORPORATION
EEG-1260A
In Commercial Distribution

  • 04931921009161 ()
EEG-1260A

  • Electroencephalograph

Nihon Kohden, EEG-1200A Series Neurofax - 04931921007730

Cart, Compact type, used with EEG-1200A, works with standard and optional accessories
NIHON KOHDEN CORPORATION
KE-122A-01
In Commercial Distribution

  • 04931921007730 ()
KE-122A-01

  • Instrument trolley

Nihon Kohden, EEG-1200A Series Neurofax - 04931921007723

Cart, used with EEG-1200A, works with standard and optional accessories
NIHON KOHDEN CORPORATION
KD-029A-01
In Commercial Distribution

  • 04931921007723 ()
KD-029A-01

  • Instrument trolley

Nihon Kohden, EEG-1200A Series Neurofax - 04931921007716

Flash lamp assembly, Round shape
NIHON KOHDEN CORPORATION
LS-706A-01
In Commercial Distribution

  • 04931921007716 ()
LS-706A-01

  • Electroencephalograph

NA - 04931921108154

Flat Pack Mini Expansion, Channel 193-256
NIHON KOHDEN CORPORATION
JE-228AK
In Commercial Distribution

  • 04931921108154 ()
JE-228AK

  • Electroencephalograph

NA - 04931921107485

Analog output unit
NIHON KOHDEN CORPORATION
QD-120A
In Commercial Distribution

  • 04931921107485 ()
QD-120A

  • Electroencephalograph

NA - 04931921004357

Bundled cable for JE-120A-256
NIHON KOHDEN CORPORATION
AAA-17041
In Commercial Distribution

  • 04931921004357 ()


  • Electroencephalograph

Stratus EEG - 05694110068064

Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Client Software
In Commercial Distribution



  • Bioelectrical signal analysis software

Stratus EEG - 05694110068057

Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Server Software
In Commercial Distribution



  • Bioelectrical signal analysis software

Stratus EEG - 05694110068040

Stratus EEG Web is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over the Web without the use of additional remote desktop software solutions. The two main components of Stratus Web are Web Centrum and Web Review.
Kvikna Medical ehf.
Web
In Commercial Distribution

  • 05694110068040 ()


  • Bioelectrical signal analysis software

Lifelines iEEG Server Software - 05694110063069

Lifelines iEEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions. The two main components of Lifelines iEEG are iEEG Centrum and iEEC Review.
Kvikna Medical ehf.
KSW2060
Not in Commercial Distribution

  • 05694110063069 ()


  • Bioelectrical signal analysis software

Lifelines iEEG Client Software - 05694110063052

Lifelines iEEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions. The two main components of Lifelines iEEG are iEEG Centrum and iEEC Review.
Kvikna Medical ehf.
KSW2050
Not in Commercial Distribution

  • 05694110063052 ()


  • Bioelectrical signal analysis software

Neurofax - 00841983104329

NEUROFAX ACQUISITION, SML FRM
NIHON KOHDEN AMERICA, INC.
EEG-1260A
In Commercial Distribution

  • 00841983104329 ()
EEG-1260A

  • Electroencephalograph

NA - 00841983103995

EEG-1200A DESKTOP SYSTEM
NIHON KOHDEN AMERICA, INC.
EEG-1200A-DT
In Commercial Distribution

  • 00841983103995 ()
EEG-1200A-DT

  • Electroencephalograph

Neurofax - 00841983103988

MEDICAL ISOLATION TRANSFORMER
NIHON KOHDEN AMERICA, INC.
A/ABC300-11MED
In Commercial Distribution

  • 00841983103988 ()
A/ABC300-11MED

  • Electroencephalograph

NEUROFAX - 00841983103971

NEUROFAX ACQUISITION, Dell Precision Tower desktop
NIHON KOHDEN AMERICA, INC.
EEG-1200A-T
In Commercial Distribution

  • 00841983103971 ()
EEG-1200A-T

  • Electroencephalograph

NEUROFAX - 00841983103926

EEG REVIEW SUITE, 5 USER LICENSE
NIHON KOHDEN AMERICA, INC.
NK-REVSUITE-5
In Commercial Distribution

  • 00841983103926 ()
NK-REVSUITE-5

  • Electroencephalograph

NEUROFAX - 00841983103919

EEG REVIEW SUITE, 10 USER LICENSE
NIHON KOHDEN AMERICA, INC.
NK-REVSUITE-10
In Commercial Distribution

  • 00841983103919 ()
NK-REVSUITE-10

  • Electroencephalograph

NEUROFAX - 00841983103858

LIVE VIEW PANEL SYSTEM
NIHON KOHDEN AMERICA, INC.
A/LVP
In Commercial Distribution

  • 00841983103858 ()
A/LVP

  • Electroencephalograph

NEUROFAX - 00841983103841

EEG REVIEW SYSTEM
NIHON KOHDEN AMERICA, INC.
A/EEGR
In Commercial Distribution

  • 00841983103841 ()
A/EEGR

  • Electroencephalograph

NEUROFAX - 00841983103834

256 CHANNEL AMPLIFIER for JE-120A
NIHON KOHDEN AMERICA, INC.
JE-120A-24
In Commercial Distribution

  • 00841983103834 ()
JE-120A-24

  • Neurophysiologic monitoring system

NEUROFAX - 00841983103827

192 CHANNEL AMPLIFIER for JE-120A
NIHON KOHDEN AMERICA, INC.
JE-120A-23
In Commercial Distribution

  • 00841983103827 ()
JE-120A-23

  • Neurophysiologic monitoring system

NEUROFAX - 00841983103810

128 CHANNEL AMPLIFIER for JE-120A
NIHON KOHDEN AMERICA, INC.
JE-120A-22
In Commercial Distribution

  • 00841983103810 ()
JE-120A-22

  • Neurophysiologic monitoring system

NEUROFAX - 00841983103797

NEUROFAX ACQUISITION, PANEL PC
NIHON KOHDEN AMERICA, INC.
EEG-1250A
In Commercial Distribution

  • 00841983103797 ()
EEG-1250A

  • Electroencephalograph
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