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510(k) Data Aggregation
K Number
K070580Device Name
NASOPHARYNGOSCOPE, BRONCHOSCOPE
Manufacturer
Date Cleared
2007-06-13
(104 days)
Product Code
Regulation Number
874.4760Why 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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