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

    CSI/QCT

    K Number: K880404 · Decision Nov 17, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    7
    Review Days
    293

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    Basic Information

    Device Name
    CSI/QCT
    K Number
    K880404
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Columbia Scientific, Inc.
    Date Received
    January 29, 1988
    Decision Date
    November 17, 1988
    Product Code
    KGI
    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
    KGI Densitometer, Bone

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