BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SACCADOMETER

    DI: 05906874392010 · Model: PLUS · OBER CONSULTING SP Z O O
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SACCADOMETER
    Primary DI
    05906874392010
    Version / Model
    PLUS
    Company Name
    OBER CONSULTING SP Z O O
    Labeler DUNS
    522393420
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-26
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    6608604e-774c-49ac-8c9a-4fa7d55887ec

    Device Description

    The Saccadometer Plus system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Plus is equipped with three red laser projectors with 10º separation, and 6 experiments are included in embedded software. The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage. Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HLL Monitor, Eye Movement

    GMDN Terms

    Code Name
    12609 Eye movement analysis system

    Identifiers

    Type ID
    Primary 05906874392010

    Customer Contacts

    Phone
    +48505940787
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K152890 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    50 – 104 Degrees Fahrenheit
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    32 – 113 Degrees Fahrenheit
    Type
    Storage Environment Temperature
    Temperature Range
    0 – 45 Degrees Celsius