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510(k) Data Aggregation

    K Number
    K103652
    Device Name
    SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8
    Manufacturer
    PHILIPS MEDICAL SYSTESMS
    Date Cleared
    2011-01-13

    (30 days)

    Product Code
    MHX
    Regulation Number
    870.1025
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    Applicant Name (Manufacturer) :

    PHILIPS MEDICAL SYSTESMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: ECG, Respiration, NBP, SpO2, IBP, CO2, Temperature.
    Device Description
    The SureSigns VM Series Patient Monitors are for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
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