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510(k) Data Aggregation

    K Number
    K123776
    Device Name
    POLARIS 100/200
    Manufacturer
    DRAGER MEDICAL GMBH
    Date Cleared
    2013-03-08

    (88 days)

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

    DRAGER MEDICAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Polaris 100/200 lights are classified as operating lights in accordance with IEC 60601-2-41 and are intended to be used for the local illumination of the surgery and treatment area on the patient in operating and treatment rooms. Double light The combination of two operating lights as an operating light system enables the use in operating and treatment rooms. Versions - Polaris 100 light - Polaris 200 light
    Device Description
    The Polaris 100/200 light is designed for use in as an operating light. For the Polaris 100/200 light, LED bulbs are used. The Polaris 100 light combines the illumination intensity of 48 white LED bulbs, the Polaris 200 light combines the illumination intensity of 66 white LED bulbs to form a homogeneous illumination volume of considerable illumination depth and low shadiness. A color temperature similar to natural light with good color rendering and dimmable illumination intensity ensure working conditions for surgical and treatment procedures.
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