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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K232466
Device Name Electric Breast Pump, model: YM-8166
Applicant
Guangdong Youmeng Electrical Technology Co., Ltd.
One Of Area A, Level 3, Bldg. 2, # 17, Keyuan 3rd Rd.
Shunde Hi Tech Industrial Park, Xiaoh
Foshan,  CN 528303
Applicant Contact Liu Zongjun
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm. 2401 Zhenye International Business Center, # 3101-90,
Qianhi Rd.
Shenzhen,  CN 518052
Correspondent Contact Candice Qiu
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/15/2023
Decision Date 01/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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