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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 K222252
Device Name Self-adhesive Electrode
Applicant
Shenzhen Roundwhale Technology Co., Ltd.
202,2/F, Building 27, Dafa Industrial Park, Longxi Community
Longgang Street, Longgang District
Shenzhen,  CN 518108
Applicant Contact Zeng Chunming
Correspondent
Shenzhen Roundwhale Technology Co., Ltd.
202,2/F, Building 27, Dafa Industrial Park, Longxi Community
Longgang Street, Longgang District
Shenzhen,  CN 518108
Correspondent Contact Amos Zou
Regulation Number882.1320
Classification Product Code
GXY  
Date Received07/27/2022
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
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