BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

    Electrical Impedance Spectrometer

    PMA: P150046 · Supplement: S006 · Decision Dec 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Electrical Impedance Spectrometer
    Trade Name
    Nevisense
    PMA Number
    P150046
    Supplement Number
    S006
    Device Class
    FDA Class 2
    Product Code
    ONV
    Generic Name
    Electrical Impedance Spectrometer
    Regulation Number
    878.1820
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 15, 2025
    Date Received
    December 2, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for an automated electrical test station and data acquisition process for quality testing of finished disposable Nevisense electrodes, while retaining the existing manual electrical test station and process

    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