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510(k) Data Aggregation

    K Number
    K090192
    Device Name
    BILI BLUE F20T12/BBY AND F40T12/BBY
    Manufacturer
    Date Cleared
    2009-04-24

    (87 days)

    Product Code
    Regulation Number
    880.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERLECTRIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Interlectric Bili Blue F20T12/BBY and F40T12/BBY lamps are used in the treatment of Hyperbilirubinemia in newborn infants. The lamps are placed in commercially available luminaries that will concentrate the blue light energy.
    Device Description
    The Interlectric Bili Blue F20T12/BBY and F40T12/BBY devices are standard 2-foot and 4-foot T-12 fluorescent lamps that contain a phosphor composition that emits blue light energy in the range between 400 - 500 nanometers and produces no energy in the ultraviolet region of the spectrum.
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