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510(k) Data Aggregation

    K Number
    K043139
    Device Name
    USCOM 1A
    Manufacturer
    Date Cleared
    2005-02-15

    (95 days)

    Product Code
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    USCOM, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    USCOM 1A records and monitors beat-to-beat cardiac heamodynamics in paediatric and adult patients. Its recording and storage of patient information provides trending information of cardiovascular performance for quantitative evaluation. The USCOM 1A is for use by clinicians in the hospital environment. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Pediatric (CWD), Cardiac (CWD).
    Device Description
    The USCOM 1A is a non-invasive tool that measures and records changes in the heamodynamic status of a patient. It is a portable Continuous Wave Doppler device using an Ultrasonic Transducer to measure blood flow. it is a portable of an easy to use touch screen display with monitoring, trending and storage The GOOM TH consisted on an odo, to a see navigates intuitive and simple screens to enter patient details and perform examinations. Targeting the patient's pulmonary or aortic valves transcutaneously, the blood flow profile can be Targeting the palifically of assisted blood flow profile, the clinician can determine a number of parameters including Stroke Volume and Cardiac Output. The USCOM 1A saves the measures in a patient file. Multiple saved measures over time are displayed The USOW TA Saves the model of the patient's change in heamodynamic status. Reports can be generated on patient measures which can be printed and exported for analysis. The device is portable, weighing less than 7 kilograms and incorporates an internal battery.
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