BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)

    K Number: K132036 · Decision Jul 1, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    116
    Applicant Total
    9
    Review Days
    365

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    Basic Information

    Device Name
    HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)
    K Number
    K132036
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
    Date Received
    July 1, 2013
    Decision Date
    July 1, 2014
    Product Code
    MSX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MSX System, Network And Communication, Physiological Monitors

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