BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Evolve Sensor

    Reg #: 3007038334 · FEI: 3007038334 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    PREXION, INC.
    Registration Number
    3007038334
    FEI Number
    3007038334
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    181 Metro Drive, Suite 190
    City
    San Jose
    State
    CA
    ZIP
    95110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230732

    Owner / Operator

    Firm Name
    PreXion, Inc.
    Operator Number
    10024360
    Address
    181 Metro Drive, Suite 190
    City
    San Jose
    State
    CA
    Postal Code
    95110
    Country
    US
    Correspondent
    Keith Huang

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    Unit, X-Ray, Extraoral With Timer EHD
    System, X-Ray, Extraoral Source, Digital MUH

    Proprietary Names

    Evolve Sensor

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device