BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Solo Pace Control

    Reg #: 3031976597 · FEI: 3031976597 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Nextern
    Registration Number
    3031976597
    FEI Number
    3031976597
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10601 Fountains Drive
    City
    Maple Grove
    State
    MN
    ZIP
    55369
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241781

    Owner / Operator

    Firm Name
    Nextern Innovation, Inc
    Operator Number
    10037078
    Address
    10601 Fountains Drive
    City
    Maple Grove
    State
    MN
    Postal Code
    55369
    Country
    US
    Correspondent
    Caroline Byrd

    Products

    Device Name Product Code
    Pulse-Generator, Pacemaker, External DTE

    Proprietary Names

    Solo Pace Control

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)