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

    Colposcope System

    K Number: K160341 · Decision Sep 14, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    55
    Applicant Total
    8
    Review Days
    219

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    Basic Information

    Device Name
    Colposcope System
    K Number
    K160341
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1630
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xuzhou Kernel Medical Equipment Co., Ltd.
    Date Received
    February 8, 2016
    Decision Date
    September 14, 2016
    Product Code
    HEX
    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
    HEX Colposcope (And Colpomicroscope)

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