Devices

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
Neurological Devices
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
Neuro Kinetics, Inc.
1 Event
- Recall of Device Recall Normative Data Template CD

Manufacturer

Neuro Kinetics, Inc.

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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