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Electric breast pump (model: M5)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223693

by Shenzhen Lutejiacheng Technology Co., Ltd.

Identifiers

510(k) Number
K223693 FDA 510(k)
FDA Product Code
HGX 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)

Electric breast pump (model: M5) by Shenzhen Lutejiacheng Technology Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K223693 24 fields · synced Jun 18, 2026