BEUDAMED
    FDA Registration Active 🇨🇳 China

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

    Reg #: 3012027770 · FEI: 3012027770 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips Healthcare - Shanghai CDC
    Registration Number
    3012027770
    FEI Number
    3012027770
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building A2, #718 Lingshi Road, JingAn District
    City
    SHANGHAI
    Country
    CN

    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

    US Agent

    Business Name
    Philips
    Contact Name
    Deborah Currlin
    Address
    222 Jacobs Street
    City
    Cambridge
    State
    MA
    ZIP
    02141
    Country
    US
    Email
    [email protected]
    Phone
    858 9452753

    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