BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIS Module

    Reg #: 3016701404 · FEI: 3016701404 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Philips North America LLC
    Registration Number
    3016701404
    FEI Number
    3016701404
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1003 Corporate Lane, STE B
    City
    Export
    State
    PA
    ZIP
    15632
    Country
    US

    Regulatory Submissions

    510(k) Number
    K003038

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

    Proprietary Names

    BIS Module

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)