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510(k) Data Aggregation

    K Number
    K061622
    Device Name
    PS SERIES
    Manufacturer
    PHOTONIC OPTISCHE GERATE GESMBH & COKG
    Date Cleared
    2007-03-05

    (266 days)

    Product Code
    FFS, FCW, GCT
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    **PHOTONIC OPTISCHE GERATE GESMBH **& COKG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is used to provide light for endoscopic devices. Those devices can be connected directly to the light source or by fiber bundles or single fibers. The device is intended for prescription use only.
    Device Description
    The cold light sources of the PS series consist of short arc metal-halide or xenon lamps, driven by electronic ballasts. Optical components such as mirrors, lenses, filters and coatings focus the light to a small diameter of typically 1.5-4mm. Fiber light guides (single or bundles) transmit the light to the application such as endoscopes.
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