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510(k) Data Aggregation

    K Number
    K081094
    Device Name
    OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
    Manufacturer
    OLYMPIC MEDICAL CORP.
    Date Cleared
    2008-06-20

    (64 days)

    Product Code
    MEC
    Regulation Number
    880.6992
    Why did this record match?
    Product Code :

    MEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment in a hot water bath at 160° - 170° F for 30 minutes.
    Device Description
    The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are used for the cleaning and high-level disinfection of reusable and disposable breathing circuit parts used in Respiratory Therapy and Anesthesia. Pasteurization kills pathogenic vegetative bacteria and viruses by immersion in water at 160° - 170° F for 30 minutes. Full immersion pasteurization has been identified by the Centers for Disease Control as suitable for high-level disinfection of all parts not used subcutaneously. The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are identical systems with the exception of the heater capacity. The Pasteurmatic 3000 has three 3,000 watt heaters for a system capacity of 9,000 watts. The Pasteurmatic 3500 has three 5,000 watt heaters for a system capacity of 15,000 watts to allow more rapid heating of the water during the pasteurization cycle when used as a combined washerpasteurizer. Both systems rotate stainless steel baskets of tubes and parts vertically in a stainless steel tank during both washing and pasteurizing. This forces water through the full length of the tubes and drives out all the air bubbles.
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