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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 K182111
Device Name DL Self-adhesive Electrode
Applicant
Shaoxing DL Healthcare Co., Ltd.
Jiulin Land, Baiguan St., Shangyu District
Shaoxing,  CN 312300
Applicant Contact Zhao Qingya
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 903, #19 Dongbao Rd., Songjiang Area,
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/06/2018
Decision Date 01/17/2019
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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