Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)

Pump, Breast, Powered

Ningbo Youhe Electrical Appliance Technology Co., Ltd.

The following data is part of a premarket notification filed by Ningbo Youhe Electrical Appliance Technology Co., Ltd. with the FDA for Youha Electric Breast Pump (models: The One, Yh-8011, Yh-8012, Yh-8019, Yy-5030); Bebebao Electric Breast Pump (model: Bb-5020); Yiyadodo Electric Breast Pump (model: Yy-5030).

Pre-market Notification Details

Device IDK203148
510k NumberK203148
Device Name:Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)
ClassificationPump, Breast, Powered
Applicant Ningbo Youhe Electrical Appliance Technology Co., Ltd. No.567, Xintang Road, Fuhai Town Cixi,  CN 315322
ContactHuang Yun Jun
CorrespondentDaniel Qiu
Shanghai Qisheng Business Consulting Co., Ltd. Room 1301, Bld 46, Jing Gu Zhong Rd. No. 58, Min Hang District Shanghai,  CN 200240
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-22
Decision Date2021-07-08

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