Devices

Device Recall Normative Data Template CD

  • Modèle / numéro de série
    Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed USA (nationwide) and the country of Canada.
  • Description du dispositif
    Normative Data Template CD for use with the I-Portal devices. || Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.
  • Manufacturer
    Neuro Kinetics, Inc.
  • 1 Event

Fabricant

Neuro Kinetics, Inc.
  • Adresse du fabricant
    Neuro Kinetics, Inc., 128 Gamma Dr, Pittsburgh PA 15238-2920
  • Société-mère du fabricant (2017)
    Neuro Kinetics Inc.
  • Source
    USFDA