BEUDAMED
    FDA Registration Active 🇺🇸 United States

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

    Reg #: 1218950 · FEI: 1218950 · 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
    1218950
    FEI Number
    1218950
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3000 Minuteman Rd
    City
    ANDOVER
    State
    MA
    ZIP
    01810
    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

    Develop Specifications But Do Not Manufacture At This Facility