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510(k) Data Aggregation

    K Number
    K023004
    Device Name
    LFRE INDIRECT LARYNGOSCOPE
    Manufacturer
    ASTRALITE CORP.
    Date Cleared
    2003-01-28

    (141 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASTRALITE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LFRE Indirect Laryngoscope may be used for examinations of the larynx and nasopharynx - 1. while conducting normal, routine physical examinations. - 2. while inspecting for causes of abnormal conditions (e.g., hoarseness, pain) presented by the patient. - 3. while inspecting for causes of abnormal conditions indicated by referring facilities.
    Device Description
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