FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
K Number: K260346
·
Decision Jun 12, 2026
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
243
Applicant Total
1
Review Days
129
Basic Information
- Device Name
- Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
- K Number
- K260346
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Polybell (Guangzhou) Limited
- Date Received
- February 3, 2026
- Decision Date
- June 12, 2026
- Product Code
- HGX
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HGX | Pump, Breast, Powered | FDA class 2 | Obstetrics/Gynecology |
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