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    K Number
    K043367
    Device Name
    GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
    Manufacturer
    LACE ELECTRONICA S.R.L.
    Date Cleared
    2005-11-17

    (344 days)

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

    LACE ELECTRONICA S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GLAID device is indicated for use in the measurement of visual electrophysiologic potentials, including the electroretinogram (ERG), pattern electroretinogram (PERG), visual evoked potential (VEP) and electrooculogram (EOG), as an aid in the diagnosis and management of Glaucoma when used in conjunction with other established methods of diagnosis and disease management.
    Device Description
    The GLAID Ocular Electrophysiology Device generates a display of photic stimuli which the patient observes as a pattern of alternating dark and white bars or checks. The electrical response of the patients' eye is monitored and recorded. The patients' response is measured using electrodes placed on the patients' face and eye.
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