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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K140200
Device Name E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES
Applicant
Neuroinvent, Inc.
5f,#123,Anmei St.,Neihu District,
Taipei City,  TW 11484
Applicant Contact CHAO-SHENT CHAO
Correspondent
Neuroinvent, Inc.
5f,#123,Anmei St.,Neihu District,
Taipei City,  TW 11484
Correspondent Contact CHAO-SHENT CHAO
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received01/27/2014
Decision Date 07/18/2014
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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