The following data is part of a premarket notification filed by Joytech Healthcare Co., Ltd. with the FDA for Electric Breast Pump.
Device ID | K172989 |
510k Number | K172989 |
Device Name: | Electric Breast Pump |
Classification | Pump, Breast, Powered |
Applicant | Joytech Healthcare Co., Ltd. No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou, CN 311100 |
Contact | Ren Yunhua |
Correspondent | Ren Yunhua Joytech Healthcare Co., Ltd. No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Hangzhou, CN 311100 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-27 |
Decision Date | 2017-12-20 |
Summary: | summary |