BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SmartScreener-Plus2

    Reg #: 1052723 · FEI: 1000113738 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    INTELLIGENT HEARING SYSTEMS CORP.
    Registration Number
    1052723
    FEI Number
    1000113738
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6860 Sw 81st St
    City
    MIAMI
    State
    FL
    ZIP
    33143
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090579

    Owner / Operator

    Firm Name
    INTELLIGENT HEARING SYSTEMS
    Operator Number
    9000078
    Address
    6860 S.W. 81ST ST., --
    City
    Miami
    State
    FL
    Postal Code
    33143
    Country
    US
    Correspondent
    EDWARD - MISKIEL

    Products

    Device Name Product Code
    Audiometer EWO
    Stimulator, Auditory, Evoked Response GWJ

    Proprietary Names

    SmartScreener-Plus2 UBS Jr Duet USBLite Solo Universal Smart Box Smart USBLite Aria

    Establishment Types

    Manufacture Medical Device