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510(k) Data Aggregation

    K Number
    K241140
    Device Name
    ViroZap Indoor Air Purifier, In Duct Model 1008
    Manufacturer
    Applied Photonix, LLC
    Date Cleared
    2024-08-01

    (99 days)

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

    Applied Photonix, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a device intended for medical purposes that is used to destroy microorganisms entrained on the filter through a photochemical reaction in the air by exposure to UV-A radiation. The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2 - a non-enveloped ssRNA virus, Phi-X174 - a non-enveloped ssDNA virus, Aspergillus brasiliensis mold spores, and Bacillus subtilis endospores entrained on the filter under the following exposure conditions: | Organism | Name | Average Maximum Log Reduction / Exposure Time<br>(hours) by Temperature | | | |------------------------|-------------------------------|-------------------------------------------------------------------------|------------------|------------------| | | | 45°F | 72°F | 110°F | | Bacteria | Staphylococcus<br>epidermidis | 4.94 / 12 hours | 4.54 / 4 hours | 4.51 / 4 hours | | Bacteria | Klebsiella aerogenes | 5.40 / 1 hour | 6.55 / 1 hour | 6.54 / 1 hour | | Virus | MS2 bacteriophage | 4.32 / 12 hours | 4.51 / 4 hours | 4.58 / 4 hours | | Virus | Phi-X174 bacteriophage | 4.39 / 12 hours | 5.24 / 4 hours | 5.14 / 4 hours | | Mold endospore | Aspergillus brasiliensis | 4.52 / 168 hours | 5.61 / 168 hours | 5.61 / 168 hours | | Bacterial<br>endospore | Bacillus Subtilis | 4.83 / 168 hours | 4.21 / 168 hours | 4.34 / 168 hours | The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2, Phi-X174, Aspergillus brasiliensis, and Bacillus subtilis in a large chamber (9.1 ft x 9.1 ft x 7 ft) at a flow rate of 500 cfm (cubic feet per minute): | Organism | Name | Average Net Log Reduction<br>in 20 Minutes | |---------------------|----------------------------|--------------------------------------------| | Bacteria | Staphylococcus epidermidis | 5.17 | | Bacteria | Klebsiella aerogenes | 5.56 | | Virus | MS2 bacteriophage | 5.00 | | Virus | Phi-X174 bacteriophage | 5.34 | | Mold endospore | Aspergillus brasiliensis | 4.50 | | Bacterial endospore | Bacillus Subtilis | 4.58 |
    Device Description
    The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a medical ultraviolet air purifier, which incorporates patented photo-electrochemical or photo-electrocatalyst (PEC) ultraviolet air purification technology that destroys bacteria in air in medical facilities. It consists of a pre-fiter, UV-A lamps, and a catalytic filter coated with a photocatalyst. The ViroZap™ has metal housing with electronic controls, and it is installed in the ducts of a building's HVAC system. It will be available in two sizes: one size with outer dimensions of 28.5 inches by 12.25 inches, and a second size with outer dimensions of 24 inches by 12.25 inches. The ViroZap 110 device has a pre-filter and a chamber equipped with 6 low energy ultraviolet LED lights (UV-A), which emit light with wavelengths between 320-400 nm, and a catalytic filter.
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