BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Diverse Specialized Accessories and IntelliVue CL 865220 charging station

    Reg #: 3000126629 · FEI: 3000126629 · Expires 2025
    View on FDA
    Products
    13
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    13

    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
    K101600

    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
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Computer, Blood-Pressure DSK
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Alarm, Blood-Pressure DSJ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Blood Pressure Cuff DXQ
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    System, Network And Communication, Physiological Monitors MSX
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Detector And Alarm, Arrhythmia DSI
    Oximeter DQA

    Proprietary Names

    Diverse Specialized Accessories and IntelliVue CL 865220 charging station 989803163211 Mobile CL Reusable Large Adult Cuff 989803163221 Mobile CL Disposable Large Adult Cuff IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H1 IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D 989803163201 Mobile CL Disposable Adult Cuff IntelliVue Multi-Measurement Module X2, SW Rev. H1 989803163191 Mobile CL Reusable Adult Cuff 989803163181 Mobile CL Disposable Small Adult Cuff IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A 989803168881 Mobile CL Transmitter Cradles 989803163251 Mobile CL NBP Cradle Kit

    Establishment Types

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