FDA-Device2014-02-19Class II
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.
Neuro Kinetics, Inc.
Hazard
The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.
Sold states
Distributed USA (nationwide) and the country of Canada.
Affected count
148
Manufactured in
128 Gamma Dr, N/A, Pittsburgh, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0966-2014Don't want to check this manually?
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