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

    PHILIPS INTELLIVUE TCG10

    K Number: K110474 · Decision Sep 30, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    16
    Applicant Total
    25
    Review Days
    224

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    Basic Information

    Device Name
    PHILIPS INTELLIVUE TCG10
    K Number
    K110474
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.2480
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
    Date Received
    February 18, 2011
    Decision Date
    September 30, 2011
    Product Code
    LKD
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKD Monitor, Carbon-Dioxide, Cutaneous

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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
    K130849 INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450
    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
    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 →