510(k) DEN130033

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

June 5, 2015

Date Received

June 12, 2013

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Computerized Cognitive Assessment Aid

Device Class

Class II

Regulation Number

882.1470

Review Panel

NE

Submission Type

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