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510(k) Data Aggregation

    K Number
    K153784
    Device Name
    NOSOGARD FILTERS
    Manufacturer
    Evoqua Water Technologies, LLC
    Date Cleared
    2016-10-21

    (295 days)

    Product Code
    NHV
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    Evoqua Water Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NOSOGARD line of filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. NOSOGARD filters are available in models suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta and models for microbial removal equal to or greater than Legionella pneumophila. The NOSOGARD is suitable for general point of use infection control for procedures such as cleaning, rinsing of equipment, hand washing and bathing where the reduction of such microorganisms in the water is desired. The Nosogard is not intended for use in the production of USP sterile water for use in infusion, injection of fluids for use in dialysis treatments.
    Device Description
    Nosogard Filters are disposable Polyethersulfone (PES) membrane filters sealed in a polypropylene housing designed to be installed by facility personnel at point of use locations where the control of bacteria in the drinking water supply is desired for device cleaning, handwashing and bathing applications. These filters are designed to be installed as attachments to faucets or as a handheld shower head.
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