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).
| Device ID | K203148 |
| 510k Number | K203148 |
| 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) |
| Classification | Pump, Breast, Powered |
| Applicant | Ningbo Youhe Electrical Appliance Technology Co., Ltd. No.567, Xintang Road, Fuhai 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 200240 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-22 |
| Decision Date | 2021-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16957031400105 | K203148 | 000 |
| 16957031400099 | K203148 | 000 |
| 16957031400082 | K203148 | 000 |
| 16957031400075 | K203148 | 000 |
| 16957031400068 | K203148 | 000 |
| 16957031400051 | K203148 | 000 |