PKQ
- Product code
- PKQ
- Device name
- Computerized Cognitive Assessment Aid
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1470
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
FDA classification 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
Official FDA classification page: PKQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).