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510(k) Data Aggregation

    K Number
    K122625
    Device Name
    GETINGE 800HC- SERIES STEAM STERILIZER
    Manufacturer
    GETINGE SOURCING LLC
    Date Cleared
    2013-05-22

    (267 days)

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

    GETINGE SOURCING LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Getinge 800HC-E Series Steam Sterilizer is intended for use by health care facilities and to be used 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 Getinge 800HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The only model designation provided in the 800HC-E Series Steam Sterilizer is 833HC-E. The model 833HC-E is available in 2 chamber sizes; 42 inches long (39.6 cu ft) and 76 inches long (72.0 cu ft). The Getinge 800HC-E Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 17 cycles can be easily accessed and custom cycle names can be designated by the user (duplicate cycles are provided to allow for user designated names). 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
    K120532
    Device Name
    GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM
    Manufacturer
    GETINGE SOURCING LLC
    Date Cleared
    2013-05-02

    (435 days)

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

    GETINGE SOURCING LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Getinge 633HC Steam Sterilizer Air Glide System is intended to provide automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The Air Glide System is used with multiple Getinge Model 633HC 51" steam sterilizers with double-door, pass-through configurations. The system consists of a single point user interface station, loading conveyor, load transport shuttles, unloading conveyor and 2 to 7 Getinge Model 633HC Steam Sterilizers.
    Device Description
    The Getinge 633HC Steam Sterilizer Air Glide System is intended to provide automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The Air Glide System is used with multiple Getinge Model 633HC 51" steam sterilizers with double-door, pass-through configurations. The system consists of a single point user interface station, loading conveyor, load transport shuttles, unloading conveyor and 2 to 7 Getinge Model 633HC Steam Sterilizers. The 633HC AGS is designed to minimize the manual handling of sterilizer loads during transfer, chamber loading and chamber unloading of 633HC steam sterilizers. Users place the load car on the AGS conveyor, scan the load car with a barcode reader, scan the required cycle from the cycle list and click OK to enter the requirements into the AGS system. The AGS now automatically moves the load car to an available sterilizer and automatically loads the sterilizer, signals the sterilizer to run the required cycle and following a successful cycle will automatically unload the sterilizer on the unload end and move the load to the unload conveyor for pick up. Users do not need to load and unload individual sterilizers. The 633HC sterilizer controls the sterilization cycle as it normally would and does not open the unload door unless the cycle completed without error.
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    K Number
    K122071
    Device Name
    GETINGE 400HC-E / SERIES STEAM STERILIZER
    Manufacturer
    GETINGE SOURCING LLC
    Date Cleared
    2013-03-12

    (239 days)

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

    GETINGE SOURCING LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Getinge 400HC-E/500HC-E Series Steam Sterilizer is intended for use by health care facilities and to be used 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 Getinge 400HC-E/500HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The model designations provided in the 400HC-E/500HC-E Series Steam Sterilizer are 422HC-E. 433HC-E. 522HC-E and 533HC-E. 400HC-E/500HC-E Steam Sterilizer employs both gravity/downward The displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 24 cycles can be easily accessed and custom cvcle names can be designated by the user (duplicate cycles are provided to allow for user designated names). 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
    K120441
    Device Name
    GETINGE 700HC-E SERIES STEAM STERILIZER
    Manufacturer
    GETINGE SOURCING LLC
    Date Cleared
    2012-05-31

    (108 days)

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

    GETINGE SOURCING LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Getinge 700HC-E 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 700HC-E Series Steam Sterilizer is available in 3 models differentiated by chamber length; 733HC-E 39 inch chamber, 733HC-E 53 inch chamber and 733HC-E 61 inch chamber.
    Device Description
    The Getinge 700HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The only model designation provided in the 700HC-E Series Steam Sterilizer is 733HC-E. The model 733HC-E is available in 3 chamber sizes; 39 inches long (21.5 cu ft), 53 inches long (29.3 cu ft) and 61 inches long 33.7 cu ft). The 733HC-E Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 22 cycles can be easily accessed and custom cycle names can be designated by the user (duplicate cycles are provided to allow for user designated names). 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
    K070657
    Device Name
    GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER
    Manufacturer
    GETINGE SOURCING LLC
    Date Cleared
    2007-04-05

    (27 days)

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

    GETINGE SOURCING LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model 633HC Series Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids not intended for direct patient contact) by means of pressurized steam.
    Device Description
    The 633HC Series Vacuum/Gravity Steam Sterilizer is intended for use in hospital and health care facilities. The device is an intermediate sized sterilizer within our product offering, it has a vertical sliding power door, upgraded control system and offers similar overall features as those on the Getinge 400HC/500HC Steam Sterilizers including a control panel (user interface) that incorporates a color display with soft key menu navigation, has the same cycle types with similar number of preset cycle types offered.
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