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

    FETAL DOPPLER

    K Number: K112911 · Decision Oct 27, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    59
    Applicant Total
    29
    Review Days
    24

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    Basic Information

    Device Name
    FETAL DOPPLER
    K Number
    K112911
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing Choice Electronic Technololgy Co., Ltd.
    Date Received
    October 3, 2011
    Decision Date
    October 27, 2011
    Product Code
    KNG
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNG Monitor, Ultrasonic, Fetal

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