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

    ELECTRODELCA

    K Number: K892659 · Decision Nov 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    9
    Review Days
    222

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    Basic Information

    Device Name
    ELECTRODELCA
    K Number
    K892659
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Oldelft Corp. of America
    Date Received
    April 13, 1989
    Decision Date
    November 21, 1989
    Product Code
    IZG
    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
    IZG System, X-Ray, Photofluorographic

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