BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (Genesis MNS)

    Reg #: 3003084417 · FEI: 3003084417 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    STEREOTAXIS, INC.
    Registration Number
    3003084417
    FEI Number
    3003084417
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    710 N. Tucker Blvd., Suite 110
    City
    Saint Louis
    State
    MO
    ZIP
    63101
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193147

    Owner / Operator

    Firm Name
    Stereotaxis
    Operator Number
    9048165
    Address
    710 N. Tucker Blvd., Suite 110
    City
    Saint Louis
    State
    MO
    Postal Code
    63101
    Country
    US

    Products

    Device Name Product Code
    System, Catheter Or Guidewire, Steerable (Magnetic) NDQ
    Catheter Remote Control System PJB

    Proprietary Names

    Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (Genesis MNS)

    Establishment Types

    Manufacture Medical Device