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510(k) Data Aggregation

    K Number
    K214120
    Device Name
    GSS610N21 Series Steam Sterilizer
    Manufacturer
    Date Cleared
    2022-05-18

    (139 days)

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

    Maquet GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Getinge GSS610N21 Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.
    Device Description
    The steam sterilizer is used by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam. The Getinge GSS610N21 Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.
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    K Number
    K201927
    Device Name
    Getinge GSS610N Series Steam Sterilizer
    Manufacturer
    Date Cleared
    2021-03-01

    (234 days)

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

    Maquet GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Getinge GSS610N Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam. The GSS610N Series Steam Sterilizer is available in 3 models differentiated by chamber length: GSS610N Model 610N10 (40.9 inch chamber), GSS610N Model 610N14 (51.1 inch chamber), and GSS610N Model 610N15 (60.6 inch chamber).
    Device Description
    The steam sterilizer is used by health care facilities to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam. The Getinge GSS610N Series Steam Sterilizer employs both with gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters
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    K Number
    K172159
    Device Name
    Getinge GSS67N Series Steam Sterilizer
    Manufacturer
    Date Cleared
    2018-01-30

    (196 days)

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

    Maquet GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Getinge GSS67N Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam. The GSS67N Series Steam Sterilizer is available in 3 models differentiated by chamber length; GSS67N Model 6710 (39 inch chamber), GSS67N Model 6713 (51 inch chamber) and GSS67N Model 6717 (67 inch chamber).
    Device Description
    The Getinge GSS67N Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. There are three model designations to identify three different chamber lengths. The model 6710 is 1000 mm (39") long, model 6713 is 1300 mm (51") long and model 6717 is 1700 mm (67") lona. The Getinge GSS67N Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 11 standard cycles can be easily accessed and custom cycle names can be designated by the user. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.
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    K Number
    K092903
    Device Name
    BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING
    Date Cleared
    2009-12-01

    (71 days)

    Product Code
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAQUET GMBH AND CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bora UP 2080, BORA UP 2080 OP and BORA UP 2080 MOUNTING are intended as extraction suction units for aspiration and removal of fluids, and infectious material from wounds or tissue either during surgery or at the patient's bedside.
    Device Description
    The MEDAP BORA is a high performance, low-noise suction pump designed for continuous operation and suitable for high flow/high vacuum. The vacuum for the MEDAP BORA is produced by an electrically driven pump unit. The pump must be operated with an overflow protection device. The overflow protection device with float prevents the unit from oversuction. In the event of a high filling level, the float rises, closes the suction line and prevents liquid from discharging. In addition, the hydrophobic bacterial and viral filter prevents the penetration of particles and liquid into the suction unit. A bacterial filter paper in the exhaust air area guarantees additional safety for patients and operators. The unit is equipped with a hydrophobic bacterial and viral filter to protect the inside of the pump from bacterial contamination. This hydrophobic bacterial and viral filter must be used when treating infectious patients. The vacuum can be set from 0 to -90kPa (0 to -675 mmHg) using a regulation switch and is controlled using a vacuum gauge.
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