BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EnSite™ X EP System SurfaceLink Module

    Reg #: 2135338 · FEI: 3005700659 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TECHNICAL SERVICES FOR ELECTRONICS, INC.
    Registration Number
    2135338
    FEI Number
    3005700659
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    177 Industrial Parkway
    City
    Jackson
    State
    MN
    ZIP
    56143
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242016

    Owner / Operator

    Firm Name
    TECHNICAL SERVICES FOR ELECTRONICS, INC.
    Operator Number
    9044482
    Address
    7800 Equitable Dr, --
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US
    Correspondent
    Rob MacNamara

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    EnSite™ X EP System SurfaceLink Module EnSite™ X EP System Radio-lucent ECG Lead set EnSite™ X EP System Connect Cable EnSite™ X EP System Radio-opaque ECG Lead set

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)