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510(k) Data Aggregation

    K Number
    K993872
    Device Name
    VANNA BATHING SYSTEM
    Manufacturer
    VANCARE, INC.
    Date Cleared
    2000-02-16

    (93 days)

    Product Code
    ILJ
    Regulation Number
    890.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    VANCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this device is the bathing and hygiene of residents/patients in hospitals, nursing homes, or assisted living facilities. The indications for use are the necessity and advisability of a clean and healthy environment in these facilities to prevent the spread of disease.
    Device Description
    The safety and usefulness of the VÄNNA Bathing System is based on a long history of use of hydro-baths with similar characteristics. As referred to previously the VÄNNA Bathing System uses similar technology and components as other devises already on the market. Technological updates have been used in the VÄNNA Bathing System in the temperature sensor and temperature read-out indicators but these differences enhance the reliability of this devise.
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