Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K212824
    Device Name
    Bluezone Model RX-450 Air Purifier
    Manufacturer
    Bluezone Products, Inc.
    Date Cleared
    2022-02-17

    (167 days)

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

    Bluezone Products, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bluezone Model RX-450 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, mold, and virus in medical facilities and occupied spaces. The Bluezone Model Rx-450 Air Purifier has been demonstrated to entrain and destroy the following exposure/working conditions: | Test Item | Average Net Log Reduction/Time @ High Fan<br>Speed. Room Temperature Test | | |-----------|---------------------------------------------------------------------------|-------------------| | Bacteria | Bacillus atrophaeus | 4.95 / 60 minutes | | Bacteria | Bacillus atrophaeus | 4.00 / 48 minutes | | Mold | Penicillium rocqueforti | 4.40 / 60 minutes | | Mold | Penicillium rocqueforti | 4.00 / 52 minutes | | Virus | MS-2 bacteriophage | 5.32 / 60 minutes | | Virus | MS-2 bacteriophage | 4.00 / 40 minutes |
    Device Description
    The Bluezone Model RX-450 is an air purification device that uses germicidal UV bulbs to inactivate viral, bacterial or fungal aerosols. The operation of the device is as follows: ambient air containing microbial aerosols is drawn into the air purifier through a prefilter and two angled aluminum honeycomb light baffles. The infective aerosols in the air are then exposed to high intensity, germicidal, ultraviolet light where the contaminants receive a UV dose of at least 10 mW*second/cm². The bacterial, fungal and viral aerosols are inactivated through the breakdown of the microbial DNA or RNA. The cleaned air is exhausted back into the room from the Bluezone Model RX-450 through an axial fan.
    Ask a Question

    Page 1 of 1