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510(k) Data Aggregation

    K Number
    K070722
    Device Name
    PLASMAIR, MODEL T2006
    Manufacturer
    AIRINSPACE B.V.
    Date Cleared
    2007-12-14

    (274 days)

    Product Code
    FRF
    Regulation Number
    880.5045
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIRINSPACE B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Plasmair Model T2006 is intended as a room air purifier/recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical cleaner. The System's dood for member of to supplement existing building air treatment and/or provide air treatment where none exists.
    Device Description
    The device uses spatially modulated, amplified multidirectional electrostatic field technology to create cold plasmas for decontamination and capture of airborne particulates.
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