The following data is part of a premarket notification filed by Shantou Huihengqi Electronic Technology Co., Ltd. with the FDA for Electric Breast Pump.
| Device ID | K211024 |
| 510k Number | K211024 |
| Device Name: | Electric Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Shantou Huihengqi Electronic Technology Co., Ltd. 501, 5/F, Block C, 14A Industrial Zone, Longhu District Shantou, CN 515000 |
| Contact | Gensong Yang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-06 |
| Decision Date | 2022-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970303251413 | K211024 | 000 |
| 06970303251406 | K211024 | 000 |
| 06970303251444 | K211024 | 000 |
| 16970303251434 | K211024 | 000 |
| 16970303251502 | K211024 | 000 |
| 06970303251529 | K211024 | 000 |