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510(k) Data Aggregation

    K Number
    K121266
    Device Name
    CARDIOSCOPE
    Manufacturer
    Date Cleared
    2012-12-11

    (229 days)

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

    PULSECOR LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CardioScope™ is a non-invasive, compact standalone measurement device that automatically measures systolic and diastolic pressure, and pulse rate in adult and pediatric patients. CardioScope also provides non-invasive central (aortic) systolic, mean and diastolic blood pressure, and pulse waveform intended for use in adult patients. CardioScope performs measurements using a conventional oscillometric method via a brachial cuff on the upper arm. The device is intended to be used under supervision by qualified healthcare personnel. Caution: Federal (USA) law restricts this device to sale by or on order of a physician.
    Device Description
    The CardioScope™ is a compact standalone measurement device that incorporates a SP10 compliant conventional oscillometric blood pressure module using a brachial cuff on the upper arm. The CardioScope first measures brachial systolic and diastolic blood pressures and pulse rate using the Oscillometric method. It then inflates the cuff to a pressure about 30 mmHg higher than systolic (Suprasystolic) pressure to acquire a further oscillometric pulse waveform. The suprasystolic pulse waveform is used in combination with the conventional upper-arm blood pressures to derive central systolic, diastolic and mean blood pressures.
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