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510(k) Data Aggregation

    K Number
    K243629
    Device Name
    Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)
    Manufacturer
    Shenzhen Root Innovation Technology Co., Ltd.
    Date Cleared
    2024-12-20

    (25 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Root Innovation Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Momcozy Wearable Breast Pump (Model: BP311, BP223, BP334, BP334, BP430) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
    Device Description
    Not Found
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