BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ST80i Stress Test System w/ Printer, Lead Sets, Electrodes

    Reg #: 3012528160 · FEI: 3012528160 · 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
    3012528160
    FEI Number
    3012528160
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1001 Murry Ridge Lane, STE A
    City
    Murrysville
    State
    PA
    ZIP
    15668
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121638

    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
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    ST80i Stress Test System w/ Printer, Lead Sets, Electrodes ST80i Stress Test System 989803180141, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Snaps 989803180131, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Grabber 989803180121, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Grabber 989803180151, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Snaps

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)