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510(k) Data Aggregation

    K Number
    K232645
    Device Name
    Airgle Room Air Purifier
    Manufacturer
    Airgle Corporation
    Date Cleared
    2024-02-16

    (170 days)

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

    Airgle Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Airgle Room Air Purifier is a free standing, air purifying device utilizing germicidal ultraviolet light (UV-C wavelengths near 254nm) intended for inactivation of indoor airborne aerosols including bacteria and virus in medical facilities and occupied spaces. The Airgle® Air Purifier has been demonstrated to destroy MS2 bacteriophage bioaerosol entrained on the filter of the subject device in the following exposure/working conditions: | Test Item(s) | Test Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5) | |-------------------|--------------------------------------------------------------------------------| | MS2 Bacteriophage | Model AG300: >4.0 Logs / 120 minutes | | MS2 Bacteriophage | Model AG600: >4.0 Logs / 120 minutes | | MS2 Bacteriophage | Model AG900: >4.0 Logs / 120 minutes |
    Device Description
    Airgle Room Air Purificr is an air purification device that employs an ultraviolet air purification technology to inactivate viral aerosols. It is a free-standing device, which has a sealed main housing including a Carbon filter, a cHEPA filter and Titanium Pro (UV-C) module. Model AG300 use a 2-in-1 filter which combine the Carbon filter and cHEPA filter. The operation of the device is as follows: 1) Room air is drawn into the device via the rear grill. 2) The process begins when air moves through the Carbon filter, which captures the large particles 3) Next, the air moves through the cHEPA filter, which captures a particle size greater than 0.3 microns. The filter is an ultra-high performance cHEPA filter, which filters respirable particulate matter with an efficiency reaching 99.3% at least. 4) Then the air moves through the Titanium Pro® module, where viral organisms are inactivated by UV-C light. 5) Purified air is then returned to the room via the front grill.
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