PKQ — Computerized Cognitive Assessment Aid Class II

FDA Device Classification

Classification Details

Product Code
PKQ
Device Class
Class II
Regulation Number
882.1470
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K161328cambridge cognition , ltd., us agent: clementi associatesCantab MobileJanuary 13, 2017
K150154vista lifesciencesANAM Test System: Military BatteryAugust 28, 2015
DEN130033cerebral assessment systemsCOGNIVUEJune 5, 2015