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510(k) Data Aggregation

    K Number
    K063681
    Device Name
    TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE
    Date Cleared
    2007-06-29

    (200 days)

    Product Code
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDILINE ITALIA S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Tecno-Gaz ANDROMEDA VACUUM CS Autoclave is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, and other facilities to sterilize heat and moisture-stable, reusable items (including dental hand pieces and and lumened devices ) that are compatible with steam sterilization. Refer to Standard Cycle Parameters for detailed information.
    Device Description
    The Tecno-Gaz ANDROMEDA VACUUM CS autoclave is a table-top Steam Sterilizer and uses saturated steam at high pressures and temperatures to kill infectious bio-organisms. The steam is generated in the sterilization chamber by an electric heating clement surrounding the chamber. Sterilization cycles are preprogrammed to complete each sterilization cycle according to the established times, temperature, and pressure parameter. These sterilization cycles are selected by an operator depending on the type of items to be sterilized. The sterilizer automatically admits a controlled volume of water into the chamber, start heating process and steam generation, sterilizes the items. At the end of sterilization process the autoclave automatically vents the steam and dries the items.
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