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510(k) Data Aggregation
K Number
K090192Device Name
BILI BLUE F20T12/BBY AND F40T12/BBY
Manufacturer
Date Cleared
2009-04-24
(87 days)
Product Code
Regulation Number
880.5700Why 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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