BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COMPASS INNOVATIONS, INC

    Reg #: 3014634069 · FEI: 3014634069 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    14
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    COMPASS INNOVATIONS, INC
    Registration Number
    3014634069
    FEI Number
    3014634069
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    990 Richard Ave Ste 110
    City
    Santa Clara
    State
    CA
    ZIP
    95050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201932

    Owner / Operator

    Firm Name
    COMPASS INNOVATIONS, INC
    Operator Number
    10061239
    Address
    990 Richards Ave Ste 110
    City
    Santa Clara
    State
    CA
    Postal Code
    95050
    Country
    US
    Correspondent
    Mei Shen

    Products

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

    Proprietary Names

    CareView 1500Cwe CareView 1800Cwe EXAMVue Duo EV14W CareView 1500P CareView 1800L CareView 1500C X-Ray Flat Panel Detectors CareView 1500Cw X-Ray Flat Panel Detectors CareView 750C X-Ray Flat Panel Detectors CareView 750Cw X-Ray Flat Panel Detectors CareView 1800Le EXAMVue Duo EV17T CareView 1800R EverestView 4343X CareView 1800Cw X-Ray Flat Panel Detector

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Remanufacture Medical Device