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510(k) Data Aggregation

    K Number
    K090556
    Device Name
    SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE
    Manufacturer
    SPACELABS HEALTHCARE MEDICAL EQUIPMENT (SUZHOU) CO
    Date Cleared
    2009-04-30

    (59 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPACELABS HEALTHCARE MEDICAL EQUIPMENT (SUZHOU) CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spacelabs élance Vital Signs Monitor is indicated for use in patient populations for: - Adult - Pediatric The Spacelabs élance Vital Signs Monitor facilitates the monitoring of: - ECG with arrhythmia detection - Respiration - Non-invasive blood pressures - Invasive blood pressures - Body temperature - Functional arterial oxygen saturation, and - Expired and/or inspired CO2. The Spacelabs élance Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
    Device Description
    The Spacelabs Healthcare Medical Equipment (Suzhou) Co., Ltd. (Spacelabs) élance Vital Signs Monitoring System (élance) is a family of portable patient monitors intended to be used by clinicians and medical qualified personnel for monitoring ECG, Respiration, NIBP, Temperature, SPO2, Invasive Blood Pressure and EtCO2. Models within the Spacelabs élance family come in two different sized viewing areas (10.2" and 12.1"), two different housing colors (white and black) and offer selected monitoring features. See the following Product Configuration List for the identified models and Spacelabs defined monitoring features.
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