BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    866062 IntelliVue Patient Monitor MX450

    Reg #: 3000126629 · FEI: 3000126629 · Expires 2025
    View on FDA
    Products
    35
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    35

    Registration Details

    Registration Name
    Philips Electronics Ltd
    Registration Number
    3000126629
    FEI Number
    3000126629
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1875 Buckhorn Gate, 5th Floor
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K130849

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    US Agent

    Business Name
    Philips
    Contact Name
    Shaylee Masilunas
    Address
    6501 Living Place
    City
    Pittsburgh
    State
    PA
    ZIP
    15206
    Country
    US
    Email
    [email protected]
    Phone
    724 8162019

    Products

    Device Name Product Code
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Alarm, Blood-Pressure DSJ
    Monitor, Carbon-Dioxide, Cutaneous LKD
    System, Signal Isolation DRJ
    Adaptor, Lead Switching, Electrocardiograph DRW
    Monitor, St Segment With Alarm MLD
    Recorder, Magnetic Tape, Medical DSH
    System, Network And Communication, Physiological Monitors MSX
    Monitor, St Segment MLC
    Electrocardiograph DPS
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Oximeter DQA
    Continuous Measurement Thermometer FLL
    Plethysmograph, Impedance DSB
    Transducer, Blood-Pressure, Extravascular DRS
    Calculator, Pulmonary Function Data BZC
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Probe, Thermodilution KRB
    Detector And Alarm, Arrhythmia DSI
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Computer, Blood-Pressure DSK
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Tester, Electrode, Surface, Electrocardiographic KRC
    Monitor, Breathing Frequency BZQ
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
    Recorder, Paper Chart DSF
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    866062 IntelliVue Patient Monitor MX450 866060 IntelliVue Patient Monitor MX400

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device