PKQ — Computerized Cognitive Assessment Aid Class II
FDA product code PKQ covers "Computerized Cognitive Assessment Aid", a Class II medical device regulated under 21 CFR 882.1470. Submissions are reviewed by the Neurology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PKQ
- Device Class
- Class II
- Regulation Number
- 882.1470
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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