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510(k) Data Aggregation

    K Number
    K072185
    Device Name
    AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000
    Manufacturer
    AIRISTAR TECHNOLOGIES, LLC
    Date Cleared
    2008-03-27

    (234 days)

    Product Code
    FRF
    Regulation Number
    880.5045
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRISTAR TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for use in filtering airborne particles from air for medical purposes.
    Device Description
    The Airistar Air Purification Systems - Model 1000 are medical air cleaners designed to help remove particulate matter from the air. These systems are for home use and use in hospitals, nursing homes, schools, offices, etc. The Model 500 Airistar Air Purification System contains software and a display panel to program runs times and fan speeds, the panel also displays filter life indicator bar. The Model 1000 Airistar Air Purification System is operated via a power switch and control knobs to adjust the fan speed. Both models have 3 fan speeds and contain a 6 Stage filter system.
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