Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
Device Facts
| Record ID | K260346 |
|---|---|
| Device Name | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) |
| Applicant | Polybell (Guangzhou) Limited |
| Product Code | HGX · Obstetrics/Gynecology |
| Decision Date | Jun 12, 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.
