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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 K210448
Device Name Adhesive Electrode
Applicant
Shaoxing Yingtuo Healthcare Co., Ltd.
#176 Shungeng Rd.,Baiguan St.,Shangyu Area,
Shaoxing City,Zhejiang
Shaoxing,  CN 312300
Applicant Contact Haze XU
Correspondent
Shaoxing Yingtuo Healthcare Co., Ltd.
#176 Shungeng Rd.,Baiguan St.,Shangyu Area,
Shaoxing City,Zhejiang
Shaoxing,  CN 312300
Correspondent Contact Haze XU
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/16/2021
Decision Date 08/31/2021
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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