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

    Electric Breast Pump

    K Number: K182413 · Decision Mar 7, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    6
    Review Days
    184

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    Basic Information

    Device Name
    Electric Breast Pump
    K Number
    K182413
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangdong Horigen Mother & Baby Products Co., Ltd.
    Date Received
    September 4, 2018
    Decision Date
    March 7, 2019
    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 Guangdong Horigen Mother & Baby Products Co., Ltd.

    K Number Device Name
    K212564 Electric Breast Pump
    K201152 Electric Breast Pump
    K201974 Single-use medical face mask
    K193449 Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
    K162747 Proture Double Electric Breast Pump