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510(k) Data Aggregation
K Number
K081094Device Name
OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
Manufacturer
OLYMPIC MEDICAL CORP.
Date Cleared
2008-06-20
(64 days)
Product Code
MEC
Regulation Number
880.6992Why 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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