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

    MRX-865

    K Number: K921130 · Decision Sep 10, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    39
    Applicant Total
    2
    Review Days
    184

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    Basic Information

    Device Name
    MRX-865
    K Number
    K921130
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1760
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mrx-Ray Tube Corp.
    Date Received
    March 10, 1992
    Decision Date
    September 10, 1992
    Product Code
    ITY
    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
    ITY Assembly, Tube Housing, X-Ray, Diagnostic

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    PHILIPS PRE-FILTER OPTION

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    MG-1001 TUBE HOUSING ASSEMBLY

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    Other Clearances by Mrx-Ray Tube Corp.

    K Number Device Name
    K921129 MRX-700