Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
Device Facts
| Record ID | K250070 |
|---|---|
| Device Name | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) |
| Applicant | Shenzhen Changkun Technology Co., Ltd. |
| Product Code | HGX · Obstetrics/Gynecology |
| Decision Date | Jun 26, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5160 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered breast pump in an electrically powered suction device used to express milk from the breast.
