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510(k) Data Aggregation

    K Number
    K092883
    Device Name
    LED LAMP OR OTHER
    Manufacturer
    INTRAVISTA MEDICAL SYSTEMS INC
    Date Cleared
    2009-12-18

    (91 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTRAVISTA MEDICAL SYSTEMS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vivid Light™ LED lamps for slit lamp biomicroscope are intended to be used as accessories for replacement of the 6V Tungsten bulb for Haag Streit's BM900, BQ900, BX900 and BP900 slit lamp biomicroscopes. Haag Streit's slit lamp biomicroscopes are indicated as noninvasive aid to the examination and diagnosis of eye conditions and in fitting of contact lenses.
    Device Description
    Vivid Light™ LED lamps for slit lamp biomicroscope
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