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510(k) Data Aggregation
K Number
K111736Device Name
TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES
Manufacturer
TUTTNAUER CO. LTD.
Date Cleared
2011-12-08
(171 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
TUTTNAUER CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EZ Plus Series autoclaves are autoclaves designed for sterilizing medical and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dentil hand pieces; suction pipes) in ophthalmic, dental, and medical clinics; in first aid rooms; and in small laboratories.
Device Description
The EZ Plus Series autoclaves are steam sterilizers composed of a sterilization chamber, electronic heating elements, a clean water reservoir, housing, and control system. The EZ Plus Series is electronically controlled, and includes four pre-programmed sterilization cycles. All components in the sterilization path are constructed of grades of stainless steel that are deemed acceptable for steam sterilizers.
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K Number
K063711Device Name
TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA
Manufacturer
TUTTNAUER CO. LTD.
Date Cleared
2007-02-02
(50 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
TUTTNAUER CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Tuttnauer autoclave is designed for use in healthcare settings for the sterilization of heat stable medical devices; wrapped solids, hollow and porous products. Sterilization of liquid loads should only be used in non-clinical applications in open or closed (but not sealed) containly si
Device Description
Tuttnauer autoclave models 6990 SP-1A: 66120 SP-1A: 69150 SP-2A: 69120 L USA SP-2A; 69180 SP-2HA; and 6690 L USA SP-1V are all prevacuum autoclaves that utilize saturated steam as the sterilizing agent. Each of these autoclaves is designed for sterilization of heat stable medical devices; wrapped solids, hollow and porous products, as well as liquids for non-clinical applications in open or closed (but not sealed) containers.
Each of the six Tuttnauer autoclave models is a steam sterilizer composed of a pressure vessel with steam jacket, heating elements, a water reservoir, a water pump, and a vacuum pump, Each autoclave is pre-programmed with twelve sterilization cycles, and each has two test programs: (1) a "Bowie & Dick Test," and (2) an "Air Leakage Test." The six autoclaves are equipped with the capability to shut down automatically. An emergency stop push button that is mounted on the front panel is an available option for customers with specific needs.
The control software, which is identical to that used in the autoclayes cleared under K032192, allows for automatic operation of all six autoclaves. The microcomputer technology employed in the autoclaves ensures that the entire cycle will operate on a fully-automatic basis. Therefore, no further intervention is necessary after setting the pre-selected parameters and starting operation of the autoclaye.
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K Number
K003470Device Name
EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870
Manufacturer
TUTTNAUER CO. LTD.
Date Cleared
2001-02-20
(104 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
TUTTNAUER CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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