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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Sleep Assessment
510(k) Number K132764
Device Name MOTION WATCH AND PRO-DIARY
Applicant
Camntech, Ltd.
Upper Pendrill Court
Papworth Everard, Cambridgeshire,  GB CB233UY
Applicant Contact HOWARD SMITH
Correspondent
Camntech, Ltd.
Upper Pendrill Court
Papworth Everard, Cambridgeshire,  GB CB233UY
Correspondent Contact HOWARD SMITH
Regulation Number882.5050
Classification Product Code
LEL  
Date Received09/04/2013
Decision Date 01/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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