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Wearable Breast Pump (P9 +7 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252192

by Huizhou LVB Maternal & Infant Supplies Co., Ltd.

Identifiers

510(k) Number
K252192 FDA 510(k)
FDA Product Code
HGX FDA 510(k)
Models / Variants
P9 FDA 510(k)
P10 FDA 510(k)
P16 FDA 510(k)
P20 FDA 510(k)
P21 FDA 510(k)
P22 FDA 510(k)
P23 FDA 510(k)
P25 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 (P9 +7 more) by Huizhou LVB Maternal & Infant Supplies Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 8 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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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) K252192 24 fields · synced Oct 9, 2026