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

    QUANTEC SPINAL MEASUEMENT SYSTEM

    K Number: K923792 · Decision Apr 20, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    631

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    Basic Information

    Device Name
    QUANTEC SPINAL MEASUEMENT SYSTEM
    K Number
    K923792
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Quantec Image Processing , Ltd.
    Date Received
    July 28, 1992
    Decision Date
    April 20, 1994
    Product Code
    LDK
    Advisory Committee
    Unknown
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LDK Device, Sensing, Optical Contour

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