BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Siemens Essenza

    Reg #: 3016998660 · FEI: 3016998660 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Owen Kane Holdings C/O Altima DIS
    Registration Number
    3016998660
    FEI Number
    3016998660
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5380 Red Bird Center Drive
    City
    Dallas
    State
    TX
    ZIP
    75237
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130262

    Owner / Operator

    Firm Name
    Owen Kane Holdings, Inc.
    Operator Number
    10075467
    Address
    29 Broadway, Suite 2200
    City
    New York
    State
    NY
    Postal Code
    10006
    Country
    US
    Correspondent
    Philip F Jacobus

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    Siemens Essenza

    Establishment Types

    Repack or Relabel Medical Device