BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Electrical Impedance Spectrometer

    PMA: P150046 · Supplement: S003 · Decision Dec 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Electrical Impedance Spectrometer
    Trade Name
    Nevisense
    PMA Number
    P150046
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    ONV
    Generic Name
    Electrical Impedance Spectrometer
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 11, 2018
    Date Received
    November 21, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Relocation of component contract manufacturer, Kitron ab, which manufactures the following major components of the Nevisense Device: Control Unit, Probe Unit, and Test Impedance Tools.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ONV Electrical Impedance Spectrometer