Identifiers
- 510(k) Number
- K241004 FDA 510(k)
- FDA Product Code
- HGX FDA 510(k)
- Models / Variants
- ABP-1508PRO FDA 510(k)ABP-1506 FDA 510(k)ABP-1306 FDA 510(k)ABP-1306 PRO FDA 510(k)M1 FDA 510(k)M3 FDA 510(k)M8 FDA 510(k)M5 FDA 510(k)M6 FDA 510(k)K1 FDA 510(k)K2 FDA 510(k)K3 FDA 510(k)K5 FDA 510(k)ABP-1306PLUS FDA 510(k)ABP-1308 FDA 510(k)M2 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5160 FDA 510(k)
- Regulation Number
- 884.5160 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Wearable Breast Pump - M8 by Huizhou LVB Maternal & Infant Supplies Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 16 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241004 | Class II | Active |
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Manufacturer
- Manufacturer
- Huizhou LVB Maternal & Infant Supplies Co., Ltd.
- FDA Applicant
- Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
Sources (1)
- FDA 510(k) K241004 24 fields · synced Jun 18, 2026