PKQ · Class II · 21 CFR 882.1470

FDA Product Code PKQ: Computerized Cognitive Assessment Aid

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

3
Total
2
Cleared
395d
Avg days
2015
Since

FDA 510(k) Cleared Computerized Cognitive Assessment Aid Devices (Product Code PKQ)

3 devices
1–3 of 3
No devices found for this product code.

About Product Code PKQ - Regulatory Context