Family of Steam sterilizers B17 B22 Series
K-Number: K161848 · 2017-02-23
ApplicantCefla S.C.
Decision Date2017-02-23
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Family of Steam sterilizers B17 B22 Series is a medical device manufactured by Cefla S.C.. It received FDA 510(k) clearance on 2017-02-23 under approval number K161848. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Family of Steam sterilizers B17 B22 Series?
Family of Steam sterilizers B17 B22 Series is a medical device that received FDA 510(k) clearance on 2017-02-23. It is manufactured by Cefla S.C.. The 510(k) number is K161848.
When was Family of Steam sterilizers B17 B22 Series approved by the FDA?
Family of Steam sterilizers B17 B22 Series received FDA 510(k) clearance on 2017-02-23, under approval number K161848.
What company makes Family of Steam sterilizers B17 B22 Series?
Family of Steam sterilizers B17 B22 Series is manufactured by Cefla S.C..
What is the FDA product code for Family of Steam sterilizers B17 B22 Series?
The FDA product code for Family of Steam sterilizers B17 B22 Series is FLE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.