BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    989803156241 Adult Disposable Metallic 5 Leadwire Electrode Set, AAMI

    Reg #: 3000126629 · FEI: 3000126629 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    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
    K080106

    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
    Electrode, Electrocardiograph DRX

    Proprietary Names

    989803156241 Adult Disposable Metallic 5 Leadwire Electrode Set, AAMI 989803156201 Adult Disposable Metallic 3 Leadwire Electrode Set, AAMI 989803156221 Adult Disposable Radiolucent 3 Leadwire Electrode Set, AAMI 989803156231 Adult Disposable Radiolucent 3 Leadwire Electrode Set, IEC 989803156261 Adult Disposable Radiolucent 5 Leadwire Electrode Set, AAMI 989803156271 Adult Disp Radiolucent 5 Leadwire Electrode Set, IEC

    Establishment Types

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