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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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The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1022
Not in Commercial Distribution

  • 05694110063014 ()


  • Electroencephalographic monitoring system
  • Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1020
Not in Commercial Distribution

  • 05694110063007 ()


  • Electroencephalograph
  • Electroencephalographic monitoring system
PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technologist / Operator in combination with Persyst EEG Review and Analysis Software on both adult and pediatric subjects at least 3 years of age for 3D visualization of the human brain function recorded with EEG and using a patient-specific MR image.
Clouds of Care
v2
In Commercial Distribution



  • Bioelectrical signal analysis software
Persyst ESI powered by Epilog provides Electrical Source Imaging as a service to a clinical user. The clinical user does not interact directly with the device. In the Persyst ESI powered by Epilog service, the device is used by Epilog operators to generate a report. Persyst ESI powered by Epilog is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
v2
In Commercial Distribution



  • Bioelectrical signal analysis software
PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
1.0.0
Not in Commercial Distribution

  • 05430000733007 ()


  • Bioelectrical signal analysis software
Electrode junction box (256 channel)
NIHON KOHDEN CORPORATION
JE-120A-24
In Commercial Distribution

  • 04931921108734 ()
JE-120A-24

  • Electroencephalograph
Electrode junction box (192 channel)
NIHON KOHDEN CORPORATION
JE-120A-23
In Commercial Distribution

  • 04931921108727 ()
JE-120A-23

  • Electroencephalograph
Electrode junction box (128 channel)
NIHON KOHDEN CORPORATION
JE-120A-22
In Commercial Distribution

  • 04931921108710 ()
JE-120A-22

  • Electroencephalograph
Electrode junction box (64 channel)
NIHON KOHDEN CORPORATION
JE-120A
In Commercial Distribution

  • 04931921108703 ()
JE-120A-21

  • Electroencephalograph
EXTENDED LAN UNIT, JE-120A
NIHON KOHDEN CORPORATION
QI-124A
In Commercial Distribution

  • 04931921108192 ()
QI-124A

  • Electroencephalograph
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