BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MX40

    Reg #: 1218950 · FEI: 1218950 · Expires 2025
    View on FDA
    Products
    9
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    Philips North America LLC
    Registration Number
    1218950
    FEI Number
    1218950
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3000 Minuteman Rd
    City
    ANDOVER
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180017

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

    Proprietary Names

    MX40 989803202421 ECG 5L Grabber, IEC, Masimo SpO2 , Tele 989803202381 MX40 Adapter 5-Lead + Masimo SpO2 989803204291 MX40 Adapter 6-Lead + Masimo SpO2 989803202391 MX40 Adapter Masimo SpO2-only 989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele

    Establishment Types

    Manufacture Medical Device