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

    G.E. MONITROL 90 AND G.E. MONITROL 15

    K Number: K902989 · Decision Oct 29, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    76
    Applicant Total
    11
    Review Days
    125

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    Basic Information

    Device Name
    G.E. MONITROL 90 AND G.E. MONITROL 15
    K Number
    K902989
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Electromek Diagnostic Systems, Inc.
    Date Received
    June 26, 1990
    Decision Date
    October 29, 1990
    Product Code
    IXR
    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
    IXR Table, Radiographic, Tilting

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