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

    FETAL ULTRASONIC MONITOR AND ACCESSORIES

    K Number: K131457 · Decision Jan 24, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    59
    Applicant Total
    10
    Review Days
    249

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    Basic Information

    Device Name
    FETAL ULTRASONIC MONITOR AND ACCESSORIES
    K Number
    K131457
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Jumper Medical Equipment Co., Ltd.
    Date Received
    May 20, 2013
    Decision Date
    January 24, 2014
    Product Code
    KNG
    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
    KNG Monitor, Ultrasonic, Fetal

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    Other Clearances by Shenzhen Jumper Medical Equipment Co., Ltd.

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