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510(k) Data Aggregation

    K Number
    K100622
    Device Name
    BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6
    Manufacturer
    Date Cleared
    2010-08-27

    (176 days)

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

    BELIMED SAUTER AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Belimed Steam Sterilizer MST-V 3-3-6 is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities ... The Belimed Steam Sterilizer MST-V 3-3-6 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1).
    Device Description
    The Belimed Steam Sterlilzers MST-V 3-3-6 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 Model 5-5-9. The small chamber size incorporates flexibility, and allows operating the sterilizers in the limited space conditions. The Belimed Steam Sterilizer MST-V 3-3-6 is designed to be used for the thermal sterilization of porous and non-porous, heat and moisture stabile materials in the healthcare facilities. Depending of the chosen cycle materials as different as textiles, unwrapped or wrapped instrument trays can be sterilized. The Belimed Steam Sterilizer MST-V 3-3-6 is factory equipped with cycles which have been tested in accordance with AAMI/ANS ST8:2008 under defined load conditions. The predicate device with a chamber volume 73 I has been validated previously.
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    K Number
    K090339
    Device Name
    BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2
    Manufacturer
    Date Cleared
    2009-09-23

    (225 days)

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

    BELIMED SAUTER AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Belimed Steam Sterilizer TOP 5000, Series 8, model 6-0-12 is designed for sterilization of nonporous and porous heat and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer TOP 5000 Series 8, model 6-0-12, is equipped with the following factoryprogrammed Sterilization cycles and values (Tables 1-3).
    Device Description
    The Belimed Steam Sterilizer TOP 5000 Series 8 is intended for use in hospital and health care facilities.
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    K Number
    K072087
    Device Name
    BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24
    Manufacturer
    Date Cleared
    2007-10-05

    (67 days)

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

    BELIMED SAUTER AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Belimed Steam Sterilizer TOP 5000, series 24, is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.
    Device Description
    The Belimed Steam Sterilizers TOP 5000 Series 24 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 TOP 5000 series 9 - 18. The larger chamber size (higher chamber) incorporates additional flexibility, and allows operating the sterilizers in an economical way (less floor space required). The Belimed Steam Sterilizer TOP 5000 Series 24 is designed to be used for the terminal Sterilization of porous and non porous, heat and moisture stabile materials in the healthcare facilities. Depending of the chosen cycle materials as different as textiles, glassware, unwrapped or wrapped instrument trays with single or multiple instruments may be sterilized.
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