Electric Breast Pump (Models: RH-228 And RH-338)

Pump, Breast, Powered

Cixi Ruihong Electric Appliance Co., Ltd.

The following data is part of a premarket notification filed by Cixi Ruihong Electric Appliance Co., Ltd. with the FDA for Electric Breast Pump (models: Rh-228 And Rh-338).

Pre-market Notification Details

Device IDK201903
510k NumberK201903
Device Name:Electric Breast Pump (Models: RH-228 And RH-338)
ClassificationPump, Breast, Powered
Applicant Cixi Ruihong Electric Appliance Co., Ltd. No. 18, Xiamaojia Road, Shuangqingpu Village, Xinpu Town, Cixi Ningbo,  CN 315322
ContactZhangkelong Zhangkelong
CorrespondentKelong Zhang
Cixi Ruihong Electric Appliance Co., Ltd. No. 18, Xiamaojia Road, Shuangqingpu Village, Xinpu Town, Cixi Ningbo,  CN 315322
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-08
Decision Date2021-04-09

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