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510(k) Data Aggregation

    K Number
    K241680
    Device Name
    Momcozy Wearable Breast Pump (BP311)
    Manufacturer
    Shenzhen Root Innovation Technology Co., Ltd.
    Date Cleared
    2024-12-20

    (192 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 Authorized
    Intended Use
    The Momcozy Wearable Breast Pump (model: BP311) is a powered breast pump 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
    Ask a Question
    K Number
    K233880
    Device Name
    Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)
    Manufacturer
    Shenzhen Root Innovation Technology Co., Ltd.
    Date Cleared
    2024-03-06

    (89 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 Authorized
    Intended Use
    The Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) is a powered breast pump 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
    Ask a Question

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