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

    Electric breast pump (Models: RH-228 and RH-338)

    K Number: K201903 · Decision Apr 9, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    2
    Review Days
    275

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    Basic Information

    Device Name
    Electric breast pump (Models: RH-228 and RH-338)
    K Number
    K201903
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cixi Ruihong Electric Appliance Co., Ltd.
    Date Received
    July 8, 2020
    Decision Date
    April 9, 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 Cixi Ruihong Electric Appliance Co., Ltd.

    K Number Device Name
    K252744 Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)