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

    PMX MOBILE X-RAY SYSTEM

    K Number: K833226 · Decision Oct 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    223
    Applicant Total
    111
    Review Days
    71

    Basic Information

    Device Name
    PMX MOBILE X-RAY SYSTEM
    K Number
    K833226
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    PHILIPS MEDICAL SYSTEMS, INC.
    Date Received
    August 18, 1983
    Decision Date
    October 28, 1983
    Product Code
    IZL
    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
    IZL System, X-Ray, Mobile

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