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

    SIMPLICITY SERIES 5

    K Number: K881634 · Decision May 17, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    33

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    Basic Information

    Device Name
    SIMPLICITY SERIES 5
    K Number
    K881634
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3725
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Quartet Technology, Inc.
    Date Received
    April 14, 1988
    Decision Date
    May 17, 1988
    Product Code
    IQA
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IQA System, Environmental Control, Powered

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