The following data is part of a premarket notification filed by Zhejiang Carebao Co., Ltd. with the FDA for Electric Breast Pump.
| Device ID | K211755 |
| 510k Number | K211755 |
| Device Name: | Electric Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Zhejiang Carebao Co., Ltd. 3, No.1, Chuangye 4th Road, Ningbo Free Trade Zone Ningbo, CN 315000 |
| Contact | Yan Xie |
| Correspondent | Iris Wang Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue Xili Town Shenzhen, CN 518000 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-07 |
| Decision Date | 2021-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973653141687 | K211755 | 000 |
| 06973653140314 | K211755 | 000 |
| 06973653140284 | K211755 | 000 |