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510(k) Data Aggregation

    K Number
    K133800
    Device Name
    ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI
    Manufacturer
    HGI INDUSTIRES
    Date Cleared
    2014-12-19

    (371 days)

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

    HGI INDUSTIRES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MDU/Rx™ medical model is an ultraviolet (UV) air purifying device intended for the reduction of bacteria and the MS2 and Phi-X174 virus in air in medical facilities. The MDU/Rx"" medical device is non sterile.
    Device Description
    The MDU/Rx" device purifies and sanitizes air by circulating ambient air through a filter into a chamber equipped with two ultraviolet (UV) lights (also called optics) with wavelengths in the range between ~100-285 nm, which encompasses the range of light called UV-C, as described in the general system design in Figure E-1.
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