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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 K220448
Device Name Disposable Non-invasive EEG Sensor
Applicant
Shenzhen Med-Link Electronics Tech Co., Ltd.
4th And 5th Floor, Bldg. Two, Hualian Industrial Zone
Xinshi Community, Dalang St.
Shenzhen,  CN 518109
Applicant Contact Yi Liu
Correspondent
Shenzhen Med-Link Electronics Tech Co., Ltd.
4th And 5th Floor, Bldg. Two, Hualian Industrial Zone
Xinshi Community, Dalang St.
Shenzhen,  CN 518109
Correspondent Contact Yi Liu
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/16/2022
Decision Date 01/19/2023
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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