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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
Product CodePKQ
Regulation Number 882.1470
Device Class 2


Premarket Reviews
ManufacturerDecision
CAMBRIDGE COGNITION LTD., US AGENT: CLEMENTI ASSOCIATES LTD.
  SUBSTANTIALLY EQUIVALENT 1
CEREBRAL ASSESSMENT SYSTEMS, INC
  GRANTED 1
VISTA LIFESCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1

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