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510(k) Data Aggregation

    K Number
    K173916
    Device Name
    Finapres Nova Noninvasive Hemodynamic Monitor
    Manufacturer
    Finapres Medical Systems B.V.
    Date Cleared
    2018-11-06

    (319 days)

    Product Code
    DXN, DQA, DRT, DSB
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Finapres Medical Systems B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject's finger. The Finapres NOVA provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals, such as heart rate variability (HRV) and Baroreflex sensitivity (BRS). Cardiac output derived from the flow signal requires a calibration with thermal dilution. The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration. When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate. When the ECG module is present, the Finapres NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor. When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration. The Finapres NOVA is intended to be used for subjects above 18 years of age. The Finapres NOVA is intended for use in hospitals, clinics, and research centers.
    Device Description
    The Finapres NOVA with FEU NC is based on existing Finapres Medical Systems B.V. product: the Finapres Nova. The current hardware that generates pressure in the Finapres NOVA contains components which are end-of-life. Therefore, they will need to be replaced. It was decided not to redesign these PCBs, but to redesign the whole pressure control hardware for reasons mentioned below. In the new NOVA with FEU NC, the wrist unit FEU of the current NOVA system is replaced by the wrist unit FEU Nano Core. The FEU Nano Core wrist unit has the capability of generating pressure in the wrist unit, whereas with the FEU wrist unit the pressure was generated in the NOVA base station. This means that the pump, printed circuit boards (PCBs) and FEU have been replaced by a new power supply PCB and the FEU NC. By moving the pressure generation and control to the Nano Core wrist unit, there is no need for a pressure cable from the base station to the wrist unit anymore, which increases the mobility of the system and patient.
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