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 | K132882 |
| 510k Number | K132882 |
| Device Name: | ELECTRIC BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD 7TH FLOOR, JINGUI BUSINESS BLDG, NO.982 CONGYUN RD BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Contact | Mike Gu |
| Correspondent | Mike Gu SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD 7TH FLOOR, JINGUI BUSINESS BLDG, NO.982 CONGYUN RD BAIYUN DISTRICT Guangzhou, Guangdong, 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 | 2013-09-13 |
| Decision Date | 2014-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10822383972258 | K132882 | 000 |
| 00822383972282 | K132882 | 000 |
| 00822383972299 | K132882 | 000 |
| 00822383972312 | K132882 | 000 |
| 00822383550299 | K132882 | 000 |
| 00822383972251 | K132882 | 000 |
| 00822383972268 | K132882 | 000 |
| 00822383972275 | K132882 | 000 |
| 50822383975592 | K132882 | 000 |
| 10822383542949 | K132882 | 000 |
| 10822383550296 | K132882 | 000 |
| 00822383564173 | K132882 | 000 |