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

    OX-600

    K Number: K920196 · Decision Oct 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    273

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    Basic Information

    Device Name
    OX-600
    K Number
    K920196
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1860
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Stardard X-Ray Sales Co.
    Date Received
    January 15, 1992
    Decision Date
    October 14, 1992
    Product Code
    KPX
    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
    KPX Changer, Radiographic Film/Cassette

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