BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM

    K Number: K940539 · Decision Mar 16, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    24
    Applicant Total
    10
    Review Days
    37

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    Basic Information

    Device Name
    STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM
    K Number
    K940539
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.6500
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Standard Imaging, Inc.
    Date Received
    February 7, 1994
    Decision Date
    March 16, 1994
    Product Code
    KPY
    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
    KPY Shield, Protective, Personnel

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