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    K Number
    K170712
    Device Name
    Accutorr 7/VS-900 Vital Signs Monitor
    Manufacturer
    Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
    Date Cleared
    2017-08-02

    (146 days)

    Product Code
    MWI, CCK, DQA, DXN, FLL
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accutorr 7/VS-900 Vital Signs Monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2), on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. The monitor also provides a Modified Early Warning Score (MEWS) for clinical assessment in adult patients.
    Device Description
    The Accutorr 7/VS-900 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. This patient monitor consists of a main unit, parameters measurement accessories, peripheral equipments or accessories.
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