BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Electrical Impedance Spectrometer

    PMA: P150046 · Supplement: S002 · Decision Jan 14, 2019
    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
    S002
    Device Class
    FDA Class 3
    Product Code
    ONV
    Generic Name
    Electrical Impedance Spectrometer
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 14, 2019
    Date Received
    July 6, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for hardware and software modifications including replacement of discontinued PC board and associated HW and SW changes; addition of radio module; LVDS ferrite bead replacement; new cells for rechargeable battery and reprogrammed battery safety circuit; replacement of speaker; software updates to adapt to new platform; NeviFile software; Quick Measurement function; reference measurement feedback dialogs.

    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