BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Spectra Q

    K Number: K191109 · Decision Jan 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    6
    Review Days
    271

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    Basic Information

    Device Name
    Spectra Q
    K Number
    K191109
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uzinmedicare Co.
    Date Received
    April 26, 2019
    Decision Date
    January 22, 2020
    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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