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U.S. Department of Health and Human Services

Product Classification

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Device computerized cognitive assessment aid
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.
Physical State Computer-administered battery of cognitive tests, computer keyboard, computer screen.
Technical Method Uses a battery of objective cognitive tests delivered by computer software to determine an individual's current level of cognitive functioning.
Target Area Brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePKQ
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurostimulation Devices Branch (NSDB)
Submission Type 510(k)
Regulation Number 882.1470
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible