BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Multi-Measurement Module X3

    Reg #: 3016701404 · FEI: 3016701404 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    Philips North America LLC
    Registration Number
    3016701404
    FEI Number
    3016701404
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1003 Corporate Lane, STE B
    City
    Export
    State
    PA
    ZIP
    15632
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182979

    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

    Products

    Device Name Product Code
    Detector And Alarm, Arrhythmia DSI
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    System, Network And Communication, Physiological Monitors MSX
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Computer, Blood-Pressure DSK
    Monitor, St Segment With Alarm MLD
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Alarm, Blood-Pressure DSJ

    Proprietary Names

    Multi-Measurement Module X3 IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800, MP5, MP5SC

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)