BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KOSTEC MEDICAL GRADE LDC MONITORS

    K Number: K123944 · Decision Sep 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    2
    Review Days
    259

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    Basic Information

    Device Name
    KOSTEC MEDICAL GRADE LDC MONITORS
    K Number
    K123944
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kostec Co., Ltd.
    Date Received
    December 20, 2012
    Decision Date
    September 5, 2013
    Product Code
    LLZ
    Advisory Committee
    Radiology
    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
    LLZ System, Image Processing, Radiological

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