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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 K213884
Device Name Disposable EEG cable
Applicant
Shenzhen Changke Connect Electronics Co., Ltd.
A1-2nd And A2 4th Floor Of Factory Bldg., #87 Of
Hengping Rd., Baoan Community, Yuanshan
Shenzhen,  CN 518115
Applicant Contact Yahui Zhou
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
Rm. 504, Block C
# 1029 Nanhai Ave., Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number882.1320
Classification Product Code
GXY  
Date Received12/13/2021
Decision Date 05/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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