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510(k) Data Aggregation

    K Number
    K113785
    Device Name
    ADHERENT VISUAL STIMULATOR GOGGLES
    Manufacturer
    ANSCHEL TECHNOLOGY, INC.
    Date Cleared
    2012-06-06

    (166 days)

    Product Code
    GWE
    Regulation Number
    882.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANSCHEL TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SightSaver™ is an evoked response photic stimulator that is used to apply a visible light stimulus to a patient's eyes for use in evoked response measurements or for electroencephalogram (EEG) activation. The SightSaver™ Visual Stimulator is designed to be used in hospital and clinical settings by trained medical personnel and is for prescription use only.
    Device Description
    The SightSaver™ Visual Stimulator is used to expose the eyes to light in order to elicit a physiological response. LEDs inside the device flash light at the eye. The SightSaver™ Visual Stimulator is disposable and made with specifically shaped self-sticking adhesive foam padding which conforms to the periocular region of the patient's face. The SightSaver™ is designed to be connected to a triggering and acquisition system which records, analyzes, or processes the patient's responses. The triggering and acquisition system is not included as part of the 510(k).
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