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.
| Device ID | K163136 |
| 510k Number | K163136 |
| Device Name: | Youha Electric Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO.,LTD. NO.226-228, SAN JIAO TIAN RD, FU HAI TOWN Cixi, CN 315322 |
| Contact | Huang Yun Jun |
| Correspondent | Daniel Qiu SHANGHAI QISHENG BUSINESS CONSULTING CO.,LTD. ROOM 1301, BLD 46, JING GU ZHONG RD., NO.58, MIN HANG DISTRICT, SHANGHAI, CN Shanghai, CN 200240 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-08 |
| Decision Date | 2017-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854878007292 | K163136 | 000 |
| 00854878007285 | K163136 | 000 |
| 00854878007063 | K163136 | 000 |
| 00854878007056 | K163136 | 000 |
| 16957031400044 | K163136 | 000 |
| 16957031400037 | K163136 | 000 |
| 16957031400020 | K163136 | 000 |
| 16957031400013 | K163136 | 000 |