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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computerized Cognitive Assessment Aid
510(k) Number K161328
FOIA Releasable 510(k) K161328
Device Name Cantab Mobile
Applicant
Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd.
Tunbridge Court, Tunbridge Lane
Bottisham,  GB CB25 9TU
Applicant Contact Nancy D. Clementi
Correspondent
Clementi Associates, Ltd.
919 Conestoga Rd., Bldg. 3, Suite 312
Rosemont,  PA  19010
Correspondent Contact Nancy D. Clementi
Regulation Number882.1470
Classification Product Code
PKQ  
Date Received05/12/2016
Decision Date 01/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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