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510(k) Data Aggregation

    K Number
    K051126
    Device Name
    CARDIOSCOPE SONOPLUS 3000
    Date Cleared
    2005-05-19

    (16 days)

    Product Code
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULSONIC AG, MEDICAL TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is a patented combination device that includes Electrocardiograph and manual Stethoscope with an integrated graphics display of ECG signal, heart rate, presence of a pacemaker, as well as a standard acoustic stethoscope that reduces interference ("Anti-Interference System") This device is intended for use as a diagnostic aid as part of physical assessment of patient by healthcare professionals or other individuals trained to administer emergency first aid or otherwise care for a patient. It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds. When the device's integral electrodes are placed on the chest of the patient, it is capable of verifying, measuring, storing and transmitting to a database the cardiac biopotential activity. The quality of the biopotential activity display depends upon user technique and environmental conditions and it is in no way meant to be diagnostic. SONOPLUS 3000 is not intended for use in intensive care. Simultaneous use with defibrillators is prohibited.
    Device Description
    This device SONOPLUS 3000 is a combination product that includes Electrocardiograph and manual Stethoscope. It displays ECG and heart rate data with automatic pacemaker detection, auto scaling of ECG amplitudes and filtering. A Windows-based software installed on an external computer allows for: - creating patient database - downloading, storing, graphically displaying as well as printing required data from device - setting date on device - communicating with PULSONIC website for software updates
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