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510(k) Data Aggregation

    K Number
    K083715
    Device Name
    BELTBEAT WF-400
    Date Cleared
    2009-09-15

    (274 days)

    Product Code
    Regulation Number
    870.2340
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    Applicant Name (Manufacturer) :

    BONUS COMMUNICACIONES SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This monitoring system is intended to be used by clinicians for ECG signals monitoring of ambulatory and nonambulatory adult and pediatric patients in health care facilities. This product is intended to be used by trained health care professionals. It is not intended for home use.
    Device Description
    The BeltBeat is a comprehensive ambulatory system solution for ECG monitoring in intermediate care units for adult and pediatic patients. The foundation of the system is a transmitter (BeltBeat WF400) that can capture and transmit ECG signals that are then processed and displayed on the Information Center (BealtBeat STC). The Information Center generates alarms and recordings, thus notifying clinicians of changes in patients' conditions. The monitoring software BeltBeat STC displays in a computer screen ECG waveforms and heart rate numerics, and may be configured to generate patient alarms and alert messages. Additionally, full recording of patient data is available. The software is capable of monitoring up to 12 patients (BeltBeat WF400 units) simultaneously. BeltBeat system is intended for 5-lead ECG monitoring.
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