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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Analyzer, Body Composition
510(k) Number K231116
Device Name Multi-parameter detector
Applicant
Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
283rd S. Min'An Rd., Xiaolan Town, Zhongshan City,
Guangdong, China
Zhongshan,  CN 528400
Applicant Contact Jerry Liang
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Square
Liuxian Ave., Xili Town, Nanshan District,
Shenzhen,  CN 518000
Correspondent Contact Liz Li
Regulation Number870.2770
Classification Product Code
MNW  
Subsequent Product Codes
DQA   DXN   FLL  
Date Received04/20/2023
Decision Date 06/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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