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U.S. Department of Health and Human Services

Product Classification
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Device computerized cognitive assessment aid
Regulation Description 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 Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.1470
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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