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510(k) Data Aggregation
K Number
K130172Device Name
BELIMED STEAM STERILIZER MST-V
Manufacturer
Date Cleared
2013-09-23
(242 days)
Product Code
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
BELIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1).
The Belimed Steam Sterilizer MST-V, model 4-4-6 is available as a single door prevacuum/gravity version.
Device Description
The Belimed Steam Sterilizer MST-V, model 4-4-6 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer Series 3-3-6.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1).
The Belimed Steam Sterilizer MST-V, model 4-4-6 is available with a single door, prevacuum/gravity.
The Belimed Steam Sterilizer MST-V is offered in the following configuration: Table 2: Dimensions
The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed to be used for the terminal sterilization of porous and non-porous, heat and moisture stabile materials in healthcare facilities.
Depending of the chosen cycle, materials including textiles, unwrapped instrument travs with single or multiple instruments may be sterilized.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is factory equipped with cycles which have been tested in accordance with ANSI/AAM1 ST8:2008 under defined load conditions. The predicate device with a chamber volume of 73 liters has been validated previously.
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