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    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
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K062716
    Why did this record match?
    Device Name :

    Bluezone Model RX-450 Air Purifier

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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
    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.

    AI/ML Overview

    The provided text describes the regulatory filing for the "Bluezone Model RX-450 Air Purifier." This device is an air purifier that uses UV-C light to inactivate airborne bacteria, mold, and viruses. The document details the device's technical specifications, indications for use, and the non-clinical testing performed to establish its performance and safety.

    Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test CompletedAcceptance CriteriaReported Device Performance
    Electrical SafetyPer UL 507: 2017 Ed. 10+R: 06Nov2018 Fans and Ventilators; CSA C22.2#113:2018 Ed. 11Passed
    Electromagnetic CompatibilityPer IEC 60601-1-2:2014 (4th Edition) General Requirements for Safety- Collateral Electromagnetic Compatibility Requirements and Tests Medical Electrical EquipmentPassed
    Safety of air-cleaning appliancesPer IEC 60335-2-65 Safety of household and similar electrical appliances Part 2: Particular requirements for air-cleaning appliancesTest specifications were met
    Ozone Emissions Testing of Household Electrostatic Air CleanersEmittance of ozone not exceeding a concentration of 0.050 ppm (UL 867 Section 40, Fifth Edition; CSA 22-2 No. 187-15, Section 7)Found in compliance with criteria
    Zero Ozone EmissionOzone
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