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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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NeckCare Assessments - 05694230564002

The NeckCare Assessments are used to measure, record, analyze, and report head motion during instructed head-neck movements.
NeckCare Holding ehf
v1.1
In Commercial Distribution



  • Biomechanical function analysis/rehabilitation software

Stratus EEG - 05694110068071

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

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 - 05694110063090

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

Lifelines iEEG Clinical Desktop System - 05694110063083

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

Lifelines iEEG Portable Yoga Tablet No Video - 05694110063076

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

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
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