BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EverestView 4343X

    Reg #: 3014634069 · FEI: 3014634069 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    COMPASS INNOVATIONS, INC
    Registration Number
    3014634069
    FEI Number
    3014634069
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2352 Walsh Ave.
    City
    Santa Clara
    State
    CA
    ZIP
    95051
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223687

    Owner / Operator

    Firm Name
    COMPASS INNOVATIONS, INC
    Operator Number
    10061239
    Address
    2352 Walsh Ave.
    City
    Santa Clara
    State
    CA
    Postal Code
    95051
    Country
    US
    Correspondent
    Mei Shen

    Products

    Device Name Product Code
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    EverestView 4343X

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device