510(k) K161328

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

January 13, 2017

Date Received

May 12, 2016

Clearance Type

Traditional

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