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

    OMNIMEDICAL AUTOMATIC 1001

    K Number: K790673 · Decision May 4, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    6
    Review Days
    25

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    Basic Information

    Device Name
    OMNIMEDICAL AUTOMATIC 1001
    K Number
    K790673
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Omnimedical
    Date Received
    April 9, 1979
    Decision Date
    May 4, 1979
    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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