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

    AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT

    K Number: K903808 · Decision Jan 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    10
    Review Days
    155

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    Basic Information

    Device Name
    AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT
    K Number
    K903808
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Advanced Med/Surg, Inc.
    Date Received
    August 20, 1990
    Decision Date
    January 22, 1991
    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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