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

    MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I

    K Number: K992694 · Decision Sep 10, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    7
    Review Days
    29

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    Basic Information

    Device Name
    MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I
    K Number
    K992694
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.1375
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Myotronics-Noromed, Inc.
    Date Received
    August 12, 1999
    Decision Date
    September 10, 1999
    Product Code
    KZM
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZM Device, Muscle Monitoring

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