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510(k) Data Aggregation

    K Number
    K072136
    Device Name
    ULTRASONIC NEBULISER MODEL 2010
    Date Cleared
    2008-07-15

    (348 days)

    Product Code
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    WILFRED KROMKER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Krömker Medizintechnik Nebulizer Model Ultra-Neb 2010 is designed to aerosolize saline solution and liquid medication by ultrasonic energy. A single patient use medication cup is available for use with medications. The device is intended for use on adult and pediatric patients who have been prescribed inhalation therapy, sputum induction, or medication for nebulization. The device is intended for use in hospitals, hospital-type facilities, nursing home, sub-acute institutions, and home environments. Caution: Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    The Ultra-Neb 2010 Ultrasonic Nebulizer is a reusable ultrasonic nebulizer for the inhalation therapy of saline solution, or of aerosol medications. It is a desktop or pole stand mounted device, containing a nebulizing chamber that can be filled by the user. Power input is provided by AC mains.
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