The following data is part of a premarket notification filed by Guangdong Horigen Mother & Baby Products Co., Ltd. with the FDA for Electric Breast Pump.
| Device ID | K212564 |
| 510k Number | K212564 |
| Device Name: | Electric Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Guangdong Horigen Mother & Baby Products Co., Ltd. No. 18, Pingnan Industrial Zone, Mianbei Street Chaoyang District Shantou, CN 515100 |
| Contact | Changxin Chen |
| Correspondent | Olivia Meng Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu Distr Guangzhou, CN 510006 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-13 |
| Decision Date | 2022-05-06 |