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510(k) Data Aggregation

    K Number
    K023015
    Device Name
    CARDIS
    Manufacturer
    Date Cleared
    2002-09-25

    (15 days)

    Product Code
    Regulation Number
    870.1425
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    Applicant Name (Manufacturer) :

    SCHWARZER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Schwarzer cardis heart catheter measuring systems with hemodynamical evaluation software are indicated for the registration, display, real-time recording, printout and storage of biophysiological data. Hemodynamic signals as intracardiac pressure and ECG signals are recorded and displayed and a number of hemodynamic calculations are performed based on the measured values of the input signals. The Schwarzer cardis systems are intended for use in catheterization labs. The Schwarzer cardis systems are indicated for use with patients of all ages under direct supervision of a physician or other trained health care professionals.
    Device Description
    The Schwarzer cardis heart catheter measuring systems with hemodynamical evaluation software are indicated for the registration, display, real-time recording, printout and storage of biophysiological data. Hemodynamic signals as intracardiac pressure and ECG signals are recorded and displayed and a number of hemodynamic calculations are performed based on the measured values of the input signals.
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