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510(k) Data Aggregation

    K Number
    K052732
    Device Name
    ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P
    Manufacturer
    ABRACAIR, INC.
    Date Cleared
    2006-02-24

    (148 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABRACAIR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Abracair Air Cleaner is intended for the reduction of aerosolized mold and bacteria within hospitals, nursing homes, medical facilities. The device may be used in occupied spaces within hospital environments such as baby an/or neonatal nurseries, hospital rooms, operating rooms, mortuaries, embalming rooms.
    Device Description
    ABRACAIR Air Cleaner, QTZ300-60 and QTZ100-24 are devices that use a 6inch xenon flash lamp, doped with titanium within a reflecting chamber to irradiate air as the air passes through a baffled chamber. An internal fan draws air through a input filter at approximately 300 cubic feet per minute (CFM) or 100 CFM determined by model number.
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