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

    IQ SYSTEM

    K Number: K922218 · Decision Dec 8, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    174
    Applicant Total
    2
    Review Days
    210

    Basic Information

    Device Name
    IQ SYSTEM
    K Number
    K922218
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1435
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    RENAISSANCE TECHNOLOGY, INC.
    Date Received
    May 12, 1992
    Decision Date
    December 8, 1992
    Product Code
    DXG
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXG Computer, Diagnostic, Pre-Programmed, Single-Function

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    Other Clearances by RENAISSANCE TECHNOLOGY, INC.

    K Number Device Name
    K981720 IQ SYSTEM