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510(k) Data Aggregation

    K Number
    K980044
    Device Name
    XENON 300MX
    Manufacturer
    PERKINELMER OPTOELECTRONICS
    Date Cleared
    1998-04-03

    (87 days)

    Product Code
    FSS
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERKINELMER OPTOELECTRONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EG&G Xenon 300mx is intended to be used with fiber optic cables for endoscopes, surgical headlamps and other lighted tools that contain fiber optic bundles. Illumination from this device is to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, borncoscopy, urology and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various surgical procedures. The Xenon 300mx Illuminator is intended for use as a high intensity light to be used with Fiberoptic cables. Applications include endoscopes, surgical headlamps, and other lighted tools that contained Fiberoptic bundles. Illumination from this device is intended to be used for observation of body cavities, hollow organs, and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, broncoscopy, urology, and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various open surgical procedures.
    Device Description
    EG&G Optoelectronics has engineered the Xenon 300mx to provide a high intensity white light source for fiber optic cables. The system consists of a single cabinet containing a power supply, a Xenon Lamp with focusing optics, a variable light attenuator, a selector for four standard fiber optic cable sizes, and a forced air cooling system.
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