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510(k) Data Aggregation

    K Number
    K991903
    Device Name
    EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
    Manufacturer
    EXCEL TECH. LTD.
    Date Cleared
    1999-08-04

    (61 days)

    Product Code
    GWE
    Regulation Number
    882.1890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Excel "Photic Stimulator" is intended The photic activation of the EEG in visual evoked potentials.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Excel Photic Stimulator." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device has been cleared for marketing based on its substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot extract the requested information from the provided text.

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