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510(k) Data Aggregation

    K Number
    K042109
    Device Name
    DIASYS INTEGRA II
    Manufacturer
    NOVACOR FRANCE
    Date Cleared
    2005-03-09

    (216 days)

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

    NOVACOR FRANCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diasys Integra II is a non-invasive Ambulatory Blood Pressure (ABP) recorder. It measures the systolic, diastolic, mean blood pressure (BP) and the heart rate (HR). It measures and records the patient position and the arterial rigidity (QKd) at the time of each BP measurement. The BP measurements can be performed using the oscillometric mode, the auscultatory mode or the ECG-gated auscultatory mode. The procedure can be: - transfert to a computer for further analysis and report printing using the DiasySoft . software - printed out directly in a report form by a printer connected to the unit . - transfert to a remote computer through a modem connected to the unit .
    Device Description
    The DIASYS INTEGRA II is a non invasive automatic ambulatory blood pressure recorder. It has two I he DITC I o it it it & erating, the auscultatory mode and the oscillometric mode. The required mode is selected with the DiasySoft Software. If neither of these modes has been specially programmed, the Scienced with the Discount of the most appropriate mode for the patient, according to its own criteria : this is the Automatic mode. The DIASYS INTEGRA II weighs about 195 gr. and contains the electronic system and pneumatic inflation/deflation module. The measurements are saved and can be printed out directly in report form by a printer connected to the unit. If a computer is used, recording conditions and criteria can be set and the a printer of the procedure can be selected, organized, stored and printed out in a fully customised report. The system is only for measurement, recording and display. It makes no diagnoses.
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