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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 K231969
Device Name BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
Applicant
Dongguanshi Yiyingmei Technology Co., Ltd.
Rm. 701, # 31 Tangxi St. Shatou, Chang'An Town
Donguang,  CN 523000
Applicant Contact Chen Jian
Correspondent
Dongguanshi Yiyingmei Technology Co., Ltd.
Rm. 701, # 31 Tangxi St. Shatou, Chang'An Town
Donguang,  CN 523000
Correspondent Contact Chen Jian
Regulation Number884.5160
Classification Product Code
HGX  
Date Received07/03/2023
Decision Date 08/30/2024
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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