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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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Onduo Care Team Console
VERILY LIFE SCIENCES LLC
SW0002
In Commercial Distribution

  • 00860000249515 ()


  • Self-care monitoring/reporting 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 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
The Stratus EEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video synchronized to the EEG. 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.
Acquisition
In Commercial Distribution



  • Bioelectrical signal analysis software
The Lifelines iEEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well 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. Acquisition systems consist of the Lifelines iEEG software, an EEG amplifier and an off the shelf computer, along with various additional options such as video cameras (1 or 2), a photic stimulator and a bag or a cart for the system.
Kvikna Medical ehf.
Acquisition
Not in Commercial Distribution

  • 05694110063090 ()


  • 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.
KHW2050
Not in Commercial Distribution

  • 05694110063083 ()


  • Electroencephalograph
  • Electroencephalographic monitoring system
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.
KHW1050
Not in Commercial Distribution

  • 05694110063076 ()


  • 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.
KHW1040
Not in Commercial Distribution

  • 05694110063045 ()


  • 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.
KHW1030
Not in Commercial Distribution

  • 05694110063038 ()


  • 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.
KHW1010
Not in Commercial Distribution

  • 05694110063021 ()


  • Electroencephalographic monitoring system
  • Electroencephalograph
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