BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Electrical Impedance Spectrometer

    PMA: P150046 · Supplement: S004 · Decision Apr 30, 2020
    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
    S004
    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
    April 30, 2020
    Date Received
    May 31, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for software changes to remove the reference measurement step from the device operation, introducing an in-device qualification module and lesion feedback mechanism to detect potential user errors.

    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