FDA-Device2015-06-24Class II
I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits.
Neuro Kinetics, Inc.
Hazard
complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.
Sold states
Worldwide distribution - US (nationwide) and Internationally to Canada and Mexico.
Affected count
140
Manufactured in
128 Gamma Dr, Pittsburgh, PA, United States
Products
I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1795-2015Don't want to check this manually?
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