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510(k) K161328

Device
Cantab Mobile
Applicant
CAMBRIDGE COGNITION LTD., US AGENT: CLEMENTI ASSOCIATES LTD.
510(k) number
K161328
Product code
PKQ  
Decision
Substantially Equivalent (SESE)
Decision date
2017-01-13
Date received
2016-05-12
Regulation
882.1470
Classification name
Computerized Cognitive Assessment Aid
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Nancy D. Clementi
Address
Tunbridge Ct., Tunbridge Ln. Bottisham GB CB25 9TU CB25 9TU

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code PKQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150154ANAM Test System: Military BatteryVista Lifesciences, Inc.2015-08-28
DEN130033COGNIVUECerebral Assessment Systems, Inc.2015-06-05

Legacy Summary#

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FDA Review#

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