BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ISCREEN VISION INC.

    Reg #: 2320749 · FEI: 3003004358 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ISCREEN VISION INC.
    Registration Number
    2320749
    FEI Number
    3003004358
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    748 WALNUT KNOLL LN STE 1
    City
    Cordova
    State
    TN
    ZIP
    38018
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102651

    Owner / Operator

    Firm Name
    iScreen Vision Inc.
    Operator Number
    9042803
    Address
    748 WALNUT KNOLL LN STE 1
    City
    Cordova
    State
    TN
    Postal Code
    38018
    Country
    US
    Correspondent
    Buck Brown

    Products

    Device Name Product Code
    Camera, Ophthalmic, Ac-Powered HKI
    Photorefractor MMF

    Proprietary Names

    iScreen Vision Screener 3000 G5 Vision Screener

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198