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).
Device ID | K201903 |
510k Number | K201903 |
Device Name: | Electric Breast Pump (Models: RH-228 And RH-338) |
Classification | Pump, Breast, Powered |
Applicant | Cixi Ruihong Electric Appliance Co., Ltd. No. 18, Xiamaojia Road, Shuangqingpu Village, Xinpu Town, Cixi Ningbo, CN 315322 |
Contact | Zhangkelong Zhangkelong |
Correspondent | Kelong Zhang Cixi Ruihong Electric Appliance Co., Ltd. No. 18, Xiamaojia Road, Shuangqingpu Village, Xinpu Town, Cixi Ningbo, CN 315322 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-07-08 |
Decision Date | 2021-04-09 |