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

    COMBINED PHYSIOLOGICAL MONITORING SYSTEM

    K Number: K002104 · Decision Oct 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    74
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    COMBINED PHYSIOLOGICAL MONITORING SYSTEM
    K Number
    K002104
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1375
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maryrose Cusimano, Ph.D. & Scott Zeff
    Date Received
    July 12, 2000
    Decision Date
    October 10, 2000
    Product Code
    IKN
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IKN Electromyograph, Diagnostic

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