BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Promaxo MRI System

    Reg #: 3006262888 · FEI: 3006262888 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    EVOLVE MANUFACTURING TECHNOLOGIES INC.
    Registration Number
    3006262888
    FEI Number
    3006262888
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    47300 Bayside Parkway
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202518

    Owner / Operator

    Firm Name
    EVOLVE MANUFACTURING TECHNOLOGIES INC.
    Operator Number
    9100955
    Address
    47300 Bayside Parkway, --
    City
    Fremont
    State
    CA
    Postal Code
    94538
    Country
    US
    Correspondent
    NOREEN - KING

    Products

    Device Name Product Code
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    Promaxo MRI System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)