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

    eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)

    K Number: K250207 · Decision Aug 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    2
    Review Days
    199

    Basic Information

    Device Name
    eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)
    K Number
    K250207
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anker Innovations Limited
    Date Received
    January 24, 2025
    Decision Date
    August 11, 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 Anker Innovations Limited

    K Number Device Name
    K254300 eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)