BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    IntelliVue Patient Monitor MX450 (866062)

    Reg #: 9610816 · FEI: 3002807167 · Expires 2025
    View on FDA
    Products
    26
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    26

    Registration Details

    Registration Name
    Philips Medizin Systeme Boeblingen GmbH
    Registration Number
    9610816
    FEI Number
    3002807167
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    HEWLETT-PACKARD STRASSE 2
    City
    BOEBLINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K223574

    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
    Deborah Currlin
    Address
    222 Jacobs Street
    City
    Cambridge
    State
    MA
    ZIP
    02141
    Country
    US
    Email
    [email protected]
    Phone
    858 9452753

    Products

    Device Name Product Code
    Monitor, Carbon-Dioxide, Cutaneous LKD
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Computer, Blood-Pressure DSK
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Calculator, Pulmonary Function Data BZC
    Full-Montage Standard Electroencephalograph GWQ
    System, Network And Communication, Physiological Monitors MSX
    Recorder, Paper Chart DSF
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Alarm, Blood-Pressure DSJ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Monitor, St Segment With Alarm MLD
    Electrocardiograph DPS
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Stimulator, Nerve, Peripheral, Electric KOI
    Analyzer, Spectrum, Electroencephalogram Signal GWS
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Oximeter DQA
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Continuous Measurement Thermometer FLL
    Monitor, Breathing Frequency BZQ
    Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK

    Proprietary Names

    IntelliVue Patient Monitor MX450 (866062) IntelliVue Patient Monitor MX500 (866064) IntelliVue Patient Monitor MX550 (866066) IntelliVue Patient Monitor MX400 (866060)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device