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510(k) Data Aggregation

    K Number
    K132037
    Device Name
    VITAL SIGNS MONITOR
    Manufacturer
    MINDRAY NORTH AMERICA
    Date Cleared
    2014-05-16

    (319 days)

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

    MINDRAY NORTH AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The monitor is intended for spot-check monitoring physiologic parameters, including SpO2, PR, NIBP and TEMP, on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
    Device Description
    The Accutorr 3 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. It consists of a main unit, parameters measurement accessories, peripheral equipments or accessories. The Accutorr 3 Vital Signs Monitor is designed to monitor a fixed set of physiological parameters including Pulse Oxygen Saturation (SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP) and Temperature (TEMP). This monitor provides 3 different SPO2 modules manufactured by Mindray, Masimo or Nellcor.
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    K Number
    K132038
    Device Name
    ACCUTORR 7 VITAL SIGNS MONITOR
    Manufacturer
    MINDRAY NORTH AMERICA
    Date Cleared
    2014-05-02

    (305 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINDRAY NORTH AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accutorr 7 Vital Signs Monitor is intended for monitoring physiologic parameters, including SpO2, PR, NIBP and TEMP, on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians
    Device Description
    The Accutorr 7 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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    K Number
    K132075
    Device Name
    PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M)
    Manufacturer
    MINDRAY NORTH AMERICA
    Date Cleared
    2014-04-18

    (289 days)

    Product Code
    MHX, DRT, DSI, DSK, DXN, FLL, MLD
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINDRAY NORTH AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Passport M Series patient monitors including models Passport 17M and Passport 12M are intended to be used for monitoring, displaying, reviewing, alarming and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, heart rate(HR)), respiration rate(RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation(SvO2/ScvO2), carbon dioxide (CO2), Oxygen(O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS) and respiration mechanics (RM). All the parameters can be applied for single adult, pediatric and neonatal patients with the exception of the follows: the arrhythmia detection, ST Segment analysis (Mortara algorithm), BIS, RM, CCO, SvO2/ScvO2 and PAWP monitoring are intended for adult and pediatric patients only. ST Segment analysis (Mindray algorithm) is intended for adult patients only. C.O. is only for use on adult patients. The ICG is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.
    Device Description
    The Passport M Series Patient Monitors (including models Passport 17M and Passport 12M) are the developed new series based on the technical platform of the BeneView T Series patient monitors. The new series, much more compact and flexible with the appearance changes, are the sub-configuration models of the BeneView T Series patient monitors by adding some parameters monitoring functions, such as continuous cardiac output (CCO) and mixed /central venous oxygen saturation (SvO2/ScvO2) monitoring. And comparing with the cleared BeneView T Series Patient Monitors using Mortara ECG algorithm, the subject patient monitors adopt Mindray Monitoring ECG Algorithm as an optional ECG algorithm to implement ECG monitoring, arrhythmia detection, and ST Segment Analysis.
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