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510(k) Data Aggregation

    K Number
    K070580
    Device Name
    NASOPHARYNGOSCOPE, BRONCHOSCOPE
    Manufacturer
    Date Cleared
    2007-06-13

    (104 days)

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

    XION GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Nasopharyngoscopes are intended to examine or treat the nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal chords. They allow the recognition of anomalies in the tissue of the accessible organs. The EF-N 14 and EF-N 14S models with their working channel allow the insertion of an instrument to carry out a biopsy.
    Device Description
    Flexible nasopharyngoscopes with or without a working channel are built of the insertion tube with its bendable distal tip, the handle, the eyepiece and the focus ring. The handle incorporates the control lever to bend the distal tip and the connectors for the leakage tester and the fibre-optic light- guide cable.
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