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510(k) Data Aggregation

    K Number
    K120392
    Device Name
    CHROMOPHARE F 628 AND F 528
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Date Cleared
    2012-02-16

    (8 days)

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

    **BERCHTOLD GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The surgical lights BERCHTOLD CHROMOPHARE® F 628 and F 528 are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
    Device Description
    The new BERCHTOLD CHROMOPHARE® F 628 and F 528 surgical lights are suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in combination with reflector technology, BERCHTOLD realizes high illumination intensity with a lower heat radiation and less pattern variation compared to previous generations of BERCHTOLD products. The light features easy-to-operate swivel arms. Each light functions with an optional integrated in-light video camera and/or with upward "EndoLite" and/or with downward "GuideLite" for endoscopic procedures. The lights could be combined among each other or with other CHROMOPHARE devices, on ceiling mounted, wall mounted and floorstand configurations.
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    K Number
    K090378
    Device Name
    CHROMOPHARE E 668
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Date Cleared
    2009-02-23

    (6 days)

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

    **BERCHTOLD GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CHROMOPHARE® E 668 is intended to be used to provide visible illumination to the surgical field of the patient. The surgical lights BERCHTOLD CHROMOPHARE® E 668 is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.
    Device Description
    The new BERCHTOLD CHROMOPHARE® E 668 surgical light is suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in this light, BERCHTOLD realizes high illumination intensity with a lower heat radiation and less pattern variation compared to previous generations of BERCHTOLD products. The light features easy-to-operate swivel arms. Each light functions with an optional integrated CCD video camera and/or with upward "EndoLite" and/or with downward "GuideLite" for endoscopic procedures. The lights could be combined among each other.
    Ask a Question

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