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510(k) Data Aggregation

    K Number
    K991562
    Device Name
    PASCAL MEDICAL AB MENIETT 20
    Manufacturer
    Date Cleared
    1999-12-28

    (238 days)

    Product Code
    Regulation Number
    874.1090
    Why did this record match?
    Applicant Name (Manufacturer) :

    PASCAL MEDICAL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Meniett 20 is indicated for symptomatic treatment of Menière's disease. The therapeutic effect of Meniett 20 is achieved by applying low frequency, low amplitude pressure pulses to the middle ear whereby inner ear endolymphatic fluids are assumed to be evacuated from the cochlea and thus relieve the patient of the symptoms associated with endolymphatic hydrops.
    Device Description
    Meniett 20 is an electronically controlled membrane pump. Meniett 20 generates dynamic pressure and consists of a pump house, electronic hardware, software and encapsulation. In connection with the pump house there is a tube to which an ear cuff is connected and through which air pressure pulses from Meniett 20 are transferred to the patient's ear canal. The construction is encapsulated in a plastic cover designed specially for Meniett 20. There is an opening for replacing the battery. With the help of a pulse shape selector, concealed in the battery compartment, there is a possibility to switch between three different pulse shapes. To start and stop the treatment there is an on/off button on the front panel. On the front panel are four indicators for communication with the patient.
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