BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cardiac Workstation 7000

    Reg #: 3016701404 · FEI: 3016701404 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    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
    K241556

    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
    Electrocardiograph DPS

    Proprietary Names

    Cardiac Workstation 7000 CW 7000 (860441) CW 5000 (860439) Wireless PIM Leadwire, 4mm banana IEC (989803223961) Wireless PIM Leadwire, 3mm needle AAMI (989803223951) Cardiac Workstation 5000

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)