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510(k) Data Aggregation

    K Number
    K130172
    Device Name
    BELIMED STEAM STERILIZER MST-V
    Manufacturer
    Date Cleared
    2013-09-23

    (242 days)

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

    BELIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1). The Belimed Steam Sterilizer MST-V, model 4-4-6 is available as a single door prevacuum/gravity version.
    Device Description
    The Belimed Steam Sterilizer MST-V, model 4-4-6 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer Series 3-3-6. The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1). The Belimed Steam Sterilizer MST-V, model 4-4-6 is available with a single door, prevacuum/gravity. The Belimed Steam Sterilizer MST-V is offered in the following configuration: Table 2: Dimensions The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed to be used for the terminal sterilization of porous and non-porous, heat and moisture stabile materials in healthcare facilities. Depending of the chosen cycle, materials including textiles, unwrapped instrument travs with single or multiple instruments may be sterilized. The Belimed Steam Sterilizer MST-V, model 4-4-6 is factory equipped with cycles which have been tested in accordance with ANSI/AAM1 ST8:2008 under defined load conditions. The predicate device with a chamber volume of 73 liters has been validated previously.
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