Celerity Incubator

Indicator, Biological Sterilization Process

STERIS Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Celerity Incubator.

Pre-market Notification Details

Device IDK213881
510k NumberK213881
Device Name:Celerity Incubator
ClassificationIndicator, Biological Sterilization Process
Applicant STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
ContactGregory Land
CorrespondentGregory Land
STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-13
Decision Date2022-07-21

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.