BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Sleepware

    Reg #: 3000126629 · FEI: 3000126629 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    2

    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
    K040595

    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
    Standard Polysomnograph With Electroencephalograph OLV
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ

    Proprietary Names

    Sleepware Alice 6 Headbox LDE LDxN Alice PSG or components LDx ECG wireset Alice 6 PSG Base Station LDE LDxS Sleepware G3

    Establishment Types

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