BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Intellivue MX40 Patient Monitor

    Reg #: 3012528160 · FEI: 3012528160 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    Philips North America LLC
    Registration Number
    3012528160
    FEI Number
    3012528160
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1001 Murry Ridge Lane, STE A
    City
    Murrysville
    State
    PA
    ZIP
    15668
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113125

    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
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    System, Network And Communication, Physiological Monitors MSX
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Detector And Alarm, Arrhythmia DSI
    Oximeter DQA
    Adaptor, Lead Switching, Electrocardiograph DRW
    Monitor, St Segment With Alarm MLD

    Proprietary Names

    Intellivue MX40 Patient Monitor 989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele 989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber 989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber 989803172221 ECG 5L Grabber, AAMI, SpO2, Tele 989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)