STERRAD VELOCITY Biological Indicator/Process Challenge Device And Reader

Indicator, Biological Sterilization Process

Advanced Sterilization Products (ASP)

The following data is part of a premarket notification filed by Advanced Sterilization Products (asp) with the FDA for Sterrad Velocity Biological Indicator/process Challenge Device And Reader.

Pre-market Notification Details

Device IDK192025
510k NumberK192025
Device Name:STERRAD VELOCITY Biological Indicator/Process Challenge Device And Reader
ClassificationIndicator, Biological Sterilization Process
Applicant Advanced Sterilization Products (ASP) 33 Technology Drive Irvine,  CA  92618
ContactElsie Kim
CorrespondentElsie Kim
Advanced Sterilization Products (ASP) 33 Technology Drive Irvine,  CA  92618
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-29
Decision Date2020-01-23
Summary:summary

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