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

Leading manufacturers include Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd., Cerebral Assessment Systems, Inc. and Vista Lifesciences, Inc..

3
Total
2
Cleared
395d
Avg days
2015
Since