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510(k) Data Aggregation

    K Number
    K201397
    Device Name
    Ultrasonic Mesh Nebulizer
    Date Cleared
    2021-06-14

    (382 days)

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

    Shenzhen Ivankaca Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultrasonic Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatic (>4 years of age), defined by the prescribed medication, and adult patients in the home, hospital and sub-acute care settings. It is not intended for use with Pentamidine.
    Device Description
    The proposed devices are vibrating mesh nebulizers that use low frequency vibration to create aerosol and deliver aerosolized medication to the lower respiratory tract by using a vibrating mesh to create aerosol and provide fine particles to the patient's lungs. The mesh plate has holes to create low velocity aerosol. The proposed devices are portable size, curvaceous body design that is convenient to hold, Which are battery powered, 3.7V d.c. internally lithium battery. The medication container capacity is 8ml maximum. For devices, they are pushed by certain circuit frequency vibration to make piezoelectric ceramic vibrate harmony that caused high speed vibration of metal mesh. And the medicine liguid will be quickly popped through micro mesh hole of metal mesh plate to be countless micro atomizing particles. This will be further transferred by inhalation treatment using masks or mouthpieces to patients' respiratory system. There are 3 models included, MY-123/MY-125/ the three models have same intended use, mechanism of action, principle and specification. The difference between three models is appearance.
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