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510(k) Data Aggregation

    K Number
    K980745
    Device Name
    SECOND WIND AIR PURIFIER
    Manufacturer
    MONAGAN ENT., INC.
    Date Cleared
    1999-04-02

    (400 days)

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

    MONAGAN ENT., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Second Wind Air Purifier was designed to be used in an HVAC system, to improve the indoor air quality. The Second Wind air purifier is recommended to be used in conjunction with a media filter, humidifying device, proper controls to run the fan and the sealing of any ductwork. The Second Wind air purifier may be, but not necessarily used in conjunction with a complete IAQ package. The use is for anyone concerned with his or her indoor air quality. The unit is easily installed within the forced air furnace and/or the air movement device within a home or business.
    Device Description
    Second Wind Air Purifier/First Breath Air Purifier Hotel, ultraviolet HVAC mounted
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