The following data is part of a premarket notification filed by Shantou Xinghe Electrical Apparatuses Co., Ltd with the FDA for Electric Breast Pump.
| Device ID | K143585 |
| 510k Number | K143585 |
| Device Name: | Electric Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD NO.8, YI ROAD, PINGBEI INDUSTRIAL ZONE CHAOYANG DISTRICT Shantou, Guangdong, CN 515100 |
| Contact | Jun Deng |
| Correspondent | Mike Gu Guangzhou Osmunda Medical Device Technical Services., Ltd. 7th Floor, Jingui Business Building, No. 982 Congyun Rd., Baiyun District, CN 510420 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-18 |
| Decision Date | 2015-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975740360711 | K143585 | 000 |
| 06975740369721 | K143585 | 000 |
| 00810115233763 | K143585 | 000 |
| 00810115233718 | K143585 | 000 |