BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IOWA ORAL PERFORMANCE ISNTRUMENT

    K Number: K920091 · Decision May 20, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    133

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    Basic Information

    Device Name
    IOWA ORAL PERFORMANCE ISNTRUMENT
    K Number
    K920091
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.1615
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Breakthrough, Inc.
    Date Received
    January 8, 1992
    Decision Date
    May 20, 1992
    Product Code
    IKE
    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
    IKE Transducer, Miniature Pressure

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