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

    Electric Breast Pump

    K Number: K211755 · Decision Dec 1, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    2
    Review Days
    177

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    Basic Information

    Device Name
    Electric Breast Pump
    K Number
    K211755
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhejiang Carebao Co., Ltd.
    Date Received
    June 7, 2021
    Decision Date
    December 1, 2021
    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 Zhejiang Carebao Co., Ltd.

    K Number Device Name
    K222782 Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)