BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)

    K Number: K251977 · Decision Oct 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    4
    Review Days
    117

    Basic Information

    Device Name
    electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)
    K Number
    K251977
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ningbo Youhe Electrical Appliance Technology Co., Ltd.
    Date Received
    June 27, 2025
    Decision Date
    October 22, 2025
    Product Code
    HGX
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HGX Pump, Breast, Powered

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    Other Clearances by Ningbo Youhe Electrical Appliance Technology Co., Ltd.

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    K242725 Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
    K203148 Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)
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