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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 K231164
Device Name Conductive carbon film electrode
Applicant
Guangzhou Xinbo Electronic Co., Ltd.
#23 Bldg., The Second Phase,
Huachuang Animation Industry Park, Panyu,
Guangzhou,  CN 511450
Applicant Contact Sammy Li
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd.,
Huangpu Distric
Guangzhou,  CN 511450
Correspondent Contact Cassie Lee
Regulation Number882.1320
Classification Product Code
GXY  
Date Received04/25/2023
Decision Date 08/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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