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    K Number
    K120318
    Device Name
    VIVI ERGON-X HF
    Manufacturer
    VIVI S.R.L.
    Date Cleared
    2012-03-06

    (33 days)

    Product Code
    MUH, EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIVI S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ergon-X-HF is an extraoral X-ray source system intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaws, and oral structures.
    Device Description
    VIVI Ergon-X HF is a device made up of a mobile and articulate double support arm. At the opposite ends of the arm are located respectively: - a central unit equipped with wall plate, extension and radio control device. This unit is the . interface on which the control panel is placed; - . the tube head with X-Ray Tube.
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