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510(k) Data Aggregation

    K Number
    K133222
    Device Name
    SAAD PATIENT MONITOR (SPM)
    Date Cleared
    2014-08-06

    (292 days)

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

    HANIN MEDICAL SERVICES CO. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SPM is indicated for monitoring heart rate, invasive blood pressure, blood oxygen saturation, and respiration on adult, pediatric and neonatal populations. SPM is indicated for monitoring and detecting arrhythmia, pacer, and QRS on adult and pediatic populations only (not intended for use on neonatal populations). SPM will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits at which point timed or alarm recordings will be produced. SPM connects to an R50 Bedside recorder, or via the Saad Patient Monitoring network (SPMS). SPM does NOT perform ST Segment analysis and it is not intended to be used in transport or ambulatory environments. MR Environment Compatibility Statement: The Saad Patient Monitors are not compatible for use in an MR Environment (MR Unsafe).
    Device Description
    Not Found
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