BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SOLO PACE INC

    Reg #: 3035372913 · FEI: 3035372913 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    SOLO PACE INC
    Registration Number
    3035372913
    FEI Number
    3035372913
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7125 Northland Ter N
    City
    Brooklyn Park
    State
    MN
    ZIP
    55428
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241781

    Owner / Operator

    Firm Name
    Solo Pace Inc
    Operator Number
    10092533
    Address
    7125 Northland Terrace North
    City
    Brooklyn Park
    State
    MN
    Postal Code
    55428
    Country
    US
    Correspondent
    Michelle Straight

    Products

    Device Name Product Code
    Pulse-Generator, Pacemaker, External DTE
    Wire, Guide, Catheter DQX
    Electrode, Pacemaker, Temporary LDF

    Proprietary Names

    Solo Pace Control SoloPace Fusion

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device