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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 K111737
Device Name DISPOSABLE ELECTRODE
Applicant
Sanibel Supply
Drejervaenget 8
Assens,  DK DK-5610
Applicant Contact ERIK NIELSEN
Correspondent
Sanibel Supply
Drejervaenget 8
Assens,  DK DK-5610
Correspondent Contact ERIK NIELSEN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received06/21/2011
Decision Date 10/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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