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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K151576
Device Name Neon EEG
Applicant
Incereb, Ltd.
Centre Of Applied Science For Health,
Institute Of Technology Tallaght
Dublin,  IE DUBLIN24
Applicant Contact PAUL PHILLIPS
Correspondent
Incereb, Ltd.
Centre Of Applied Science For Health,
Institute Of Technology Tallaght
Dublin,  IE DUBLIN24
Correspondent Contact PAUL PHILLIPS
Regulation Number882.1320
Classification Product Code
GXY  
Date Received06/11/2015
Decision Date 09/29/2015
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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