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510(k) Data Aggregation

    K Number
    K082599
    Device Name
    NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT
    Manufacturer
    CNSYSTEM MEDIZINTECHNIK AG
    Date Cleared
    2008-10-17

    (39 days)

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

    CNSYSTEM MEDIZINTECHNIK AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CNAP Monitor 500 is intended for the monitoring of non-invasive continuous blood pressure and pulse rate in hospitals, clinical institutions, medical practices and outpatient settings. The device displays the blood pressure waveform and generates trends, beat numerics and alarms for the parameters blood pressure and pulse rate. The CNAP Monitor 500 is to be used for adults and pediatric patients from the age of 4 year and is to be operated by physicians and other medical professional staff.
    Device Description
    The CNAP™ Monitor 500 is a device for continuous non-invasive blood pressure monitoring. The device measures continuous and oscillometric blood pressure as well as pulse rate. CNAP is a joint solution, where absolute blood pressure values are coming from an integrated OEM oscillometric blood pressure device and beat-to-beat changes as well as waveform are measured with the CNAP finger sensor. Finger-BP is automatically calibrated to absolute NIBP-values. Immediately after a NIBP, the CNAP computer puts systolic and diastolic finger BP on the same level as NIBP values. NIBP calibrations can be obtained ipsilateral as well as contralateral to the CNAP-cuff.
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