BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EnSite™ X EP System ECG Output Module

    Reg #: 2133772 · FEI: 3000209794 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Spartronics Watertown LLC
    Registration Number
    2133772
    FEI Number
    3000209794
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2920 KELLY AVE
    City
    Watertown
    State
    SD
    ZIP
    57201
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242016

    Owner / Operator

    Firm Name
    Spartronics Watertown LLC
    Operator Number
    10045726
    Address
    2920 Kelly Avenue, PO Box 430
    City
    Watertown
    State
    SD
    Postal Code
    57201
    Country
    US
    Correspondent
    Evan McConnell

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    EnSite™ X EP System ECG Output Module EnSite™ X EP System Catheter Input Module

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)