BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Exo Iris

    Reg #: 3017487805 · FEI: 3017487805 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Exo Imaging, Inc.
    Registration Number
    3017487805
    FEI Number
    3017487805
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4201 Burton Drive
    City
    Santa Clara
    State
    CA
    ZIP
    95054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222198

    Owner / Operator

    Firm Name
    Exo Imaging
    Operator Number
    10085070
    Address
    4201 Burton Drive
    City
    Santa Clara
    State
    CA
    Postal Code
    95054
    Country
    US
    Correspondent
    Mugdha Dongre

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    Exo Iris

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility