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510(k) Data Aggregation

    K Number
    K132551
    Device Name
    ZF 720
    Manufacturer
    UMBEL CORPORATION
    Date Cleared
    2014-06-30

    (320 days)

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

    UMBEL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shadowless Operation Light ZF 720 is intended to be used to provide visible illumination of the surgical area or the patient with high intensity and shadow free light during surgical procedures.
    Device Description
    The Surgical Light ZF 720 is applicable for Open surgery, Endoscope surgery or other surgical procedures. With ceiling, wall and floor versions, the Surgical Light ZF 720 Systems are well-suited for various operating rooms. The device can be adjusted the color temperature, light intensity and light focus in accordance with the different visual habit by the users. And it is workable to connect to the monitor, video or other expansion devices with the requirements of the surgical environment. The Surgical Light ZF 720 consists of base assembly, pendent system and light head assembly integrated into one system. The Surgical Light ZF 720 provides optimum shadow resolution and ease of maneuverability. And the extension arm on the central block possesses the movement mechanism which enables the light heads swivel in all directions. With ceiling, wall and floor versions, the Surgical Light ZF 720 is well-suited for various operating rooms. It is also available in single, dual and triple configurations in compliance with users' requirements. The software is equipped in the device. Dispense with training before using the device.
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