BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    453564561901 M_BIS OEM BIS LoC 4-CH Device PWR Link

    Reg #: 3038281851 · FEI: 3038281851 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Philips Polska Sp. z o.o.
    Registration Number
    3038281851
    FEI Number
    3038281851
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Pilsudskiego 88
    City
    Lodz Lodzkie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K072286

    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 MEDICAL SYSTEMS INTERNATIONAL BV
    Contact Name
    Heather El-Homsi
    Address
    1001 Murry Ridge Lane, STE A
    City
    Murrysville
    State
    PA
    ZIP
    15668
    Country
    US
    Email
    [email protected]
    Phone
    440 8694932

    Products

    Device Name Product Code
    Reduced- Montage Standard Electroencephalograph OMC
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Index-Generating Electroencephalograph Software OLW
    Burst Suppression Detection Software For Electroencephalograph ORT

    Proprietary Names

    453564561901 M_BIS OEM BIS LoC 4-CH Device PWR Link 453564453711 M_BIS BISx Power Link 451261003621 M_BIS BISx Power Link ROHS

    Establishment Types

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