PKQ

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Computerized Cognitive Assessment Aid

Device class

Class II (moderate risk)

Regulation

21 CFR 882.1470

Medical specialty

Neurology

FDA definition

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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