510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PKQClass II

Computerized Cognitive Assessment Aid

21 CFR 882.1470 / Neurology
FDA source (opens on fda.gov)

PKQ is the FDA product code for Computerized Cognitive Assessment Aid, a class II device type, regulated under 21 CFR 882.1470. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PKQ
Device name
Computerized Cognitive Assessment Aid
FDA 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
Regulation
21 CFR 882.1470
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code PKQ

By decision year
3 clearances under product code PKQ with a decision year between 2015 and 2017, 2015 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PKQ by decision year
YearClearances
20152
20171

Applicants with the most clearances

Product code PKQ
Applicants holding the most 510(k) clearances under product code PKQ
ApplicantClearances
Cambridge Cognition, Ltd., US Agent: Clementi Associates, Ltd.1
Cerebral Assessment Systems, Inc.1
Vista Lifesciences, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code