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510(k) Data Aggregation

    K Number
    K161468
    Device Name
    Transformair Indoor Air Purifier
    Manufacturer
    Transformair, LLC
    Date Cleared
    2017-02-08

    (257 days)

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

    Transformair, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Transformair Indoor Air Purifier, In Duct Model 16108 is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation. Transformair Indoor Air Purifier, In Duct Model 16108 has been demonstrated to destroy Staphylococcus epidermidis, Escherichia coli, MS2, Phi-X174, Aspergillus Niger and Bacillus globigii entrained on the filter of the subject device under the following exposure conditions: | Organism | Name | Average Maximum log reduction /exposure time (hours) | | | |---------------------|-------------------|------------------------------------------------------|-------------------|-------------------| | | | Test temperature | | | | | | 45°F | 72°F | 110°F | | Bacteria | Staphylococcus | 4.88 / 24 hours | 4.02 / 0.33 hours | 4.20 / 0.33 hours | | Bacteria | Escherichia coli | 4.31 / 24 hours | 4.79 / 24 hours | 4.40 / 0.33 hours | | Virus | MS2 bacteriophage | 4.13 / 24 hours | 4.25 / 24 hours | 5.51 / 24 hours | | Virus | Phi-X174 | 4.37 / 24 hours | 4.37 / 24 hours | 4.37 / 24 hours | | Mold endospore | Aspergillus Niger | 3.91 / 72 hours | 3.99 / 72 hours | 4.22 / 72 hours | | Bacterial endospore | Bacillus globigii | 4.11 / 72 hours | 4.41 / 72 hours | 4.41 / 72 hours |
    Device Description
    Transformair® is a patented photo-electrochemical or photo-electrocatalyst (PEC) ultraviolet air purification technology that destroys bacteria in air in medical facilities. It consists of a pre-filter, black light lamps, and a catalytic filter coated with a photocatalyst. The Transformair device has a metal housing with electronic controls and outer dimensions of 28.5 inches by 21 inches by 12.25 inches that is installed in the duct of a buildings HVAC system. The Transformair device has a pre-filter and a chamber equipped with 6 low energy ultraviolet lights (UV-A), which emit light with wavelengths between 320-400 nm, and a catalytic filter.
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