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Computerized Cognitive Assessment Aid

FDA product code PKQ · 1 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.1470
Review panel
NE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-01-13 – 2017-01-13

The computerized cognitive assessment aid provides clinicians in a healthcare setting with objective measurements of cognitive function as a screening aid in the assessment of adults 55 years of age and older. This is done for the purpose of identifying a potential decline in cognitive function relative to baseline test performance of other age-normal adults, referring those adults for further testing where warranted, and monitoring changes in cognitive function over time

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