DeviceClearance

Product code PKQ— Neurology

ANAM Test System: Military Battery

Classification name
Computerized Cognitive Assessment Aid
Device class
Class 2
Regulation
21 CFR 882.1470
Advisory panel
Neurology
Total cleared
3
First cleared
Most recent

FDA classification 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”

— U.S. Food and Drug Administration, device classification record for product code PKQ under 21 CFR 882.1470, via openFDA

Market context for product code PKQ

FDA has cleared 3 devices under product code PKQ between 2015 and 2017, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PKQ

Recent clearances under product code PKQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.