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510(k) Data Aggregation

    K Number
    K132892
    Device Name
    TEBCO-W
    Manufacturer
    Date Cleared
    2014-08-01

    (319 days)

    Product Code
    Regulation Number
    870.1435
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOMED INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Adults, Hospital, Cardiology, Internal medicine TEBCO-W is indicated for noninvasive, continuous assessment and monitoring of the left-ventricular performance and global blood flow (Stroke Index, SI and Cardiac Index, CI) in adults, where use of invasive catheters is contraindicated. The device may be used only on the order of a physician and is "By prescription only." The intended use is physician's office and cardiovascular physiology laboratory.
    Device Description
    TEBCO-W is the substantially equivalent wireless version of the existing tethered predicate device TEBCO (Thoracic Electrical Bioimpedance Cardiac Output, K962128). Both the TEBCO and TEBCO-W are a hardware component of a system for noninvasive measurement of Cardiac Output and other cardiodynamic parameters. The system comprises of TEBCO (or TEBCO-W) and a PC, which acts as a host system. TEBCO (or TEBCO-W) acquire the TEB and data via a patient cable attached to 8 electrodes placed on a patient's thorax. 4 out of 8 electrodes are also used to detect a patient's ECG signal, which is utilized by both devices as a system clock. They sample the instantaneous TEB values @ 5 msec sample rate, and send continuously the binary values of digital samples in packets every 20 msec via a serial communication link to a host system (a PC), where the TEB signals are reconstructed and displayed. Both TEBCO and TEBCO-W also measure the magnitude and timing of the TEB signal in reference to Q-time of the QRS complex, from which the Heart Rate and Stroke Index are calculated, calculate then the value of Cardiac Output and sent the digital values of these parameters via the same serial link once every heartbeat to the host system, where they are displayed.
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