BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450

    K Number: K130849 · Decision Jun 14, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    25
    Review Days
    80

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    Basic Information

    Device Name
    INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450
    K Number
    K130849
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
    Date Received
    March 26, 2013
    Decision Date
    June 14, 2013
    Product Code
    MHX
    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
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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    Other Clearances by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

    K Number Device Name
    K141015 INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT
    K132320 INTELLIVUE CL RESPIRATION POD
    K131872 INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
    K131829 INTELLIVUE PATIENT MONITOR
    K120366 INTELLIVUE PATIENT MONITOR
    K113441 PHYSIOLOGICAL MONITOR, PATIENT MONITOR
    K111905 INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216
    K110474 PHILIPS INTELLIVUE TCG10
    K111083 PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
    K110622 INTELLIVUE PATIENT MONITOR
    Search all 25 clearances from Philips Medizinsysteme Boeblingen GmbH, Cardiac AN →