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510(k) Data Aggregation

    K Number
    K203189
    Device Name
    AEROCURE-MD
    Manufacturer
    Aerobiotix, Inc.
    Date Cleared
    2021-01-21

    (86 days)

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

    Aerobiotix, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aerobiotix AEROCURE-MD air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation. In addition, the device removes particles from the air via HEPA filtration.
    Device Description
    The AEROCURE-MD is a free-standing flow-through air purification device which uses germicidal ultraviolet light with supplemental HEPA filtration to remove airborne contamination. The AEROCURE-MD device has a wheeled metal housing with electrical controls and outer dimensions of 74 x 62 x 178 cm which is placed within a room. The device has a pleated pre-filter, ultraviolet photolytic chamber equipped with germicidal ultraviolet lamps, and a 99.97% HEPA filter. The AEROCURE-MD is for over-the-counter use.
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