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

    KAISHOU VAGINAL SPECULUM

    K Number: K030761 · Decision Jun 9, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    71
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    KAISHOU VAGINAL SPECULUM
    K Number
    K030761
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jiangsu Kaishou Medical Apparatus Co., Ltd.
    Date Received
    March 11, 2003
    Decision Date
    June 9, 2003
    Product Code
    HIB
    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
    HIB Speculum, Vaginal, Nonmetal

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