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

    Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)

    K Number: K241322 · Decision Dec 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    22
    Review Days
    223

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    Basic Information

    Device Name
    Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)
    K Number
    K241322
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Joytech Healthcare Co. , Ltd.
    Date Received
    May 10, 2024
    Decision Date
    December 19, 2024
    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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    K230566 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
    K213189 Wrist-type Fully Automatic Digital Blood Pressure Monitor
    K212115 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
    K200649 Arm-Type Fully Automatic Digital Blood Pressure Monitor
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