Device Recall Normative Data Template CD

  • Model / Serial
    Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed USA (nationwide) and the country of Canada.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Neuro Kinetics, Inc., 128 Gamma Dr, Pittsburgh PA 15238-2920
  • Manufacturer Parent Company (2017)
  • Source
    USFDA