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FDA 510(k)

Enbio S

K-Number: K213991 · 2022-02-22

ApplicantEnbio Group AG
Decision Date2022-02-22
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Enbio S is a medical device manufactured by Enbio Group AG. It received FDA 510(k) clearance on 2022-02-22 under approval number K213991. 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 Enbio S?

Enbio S is a medical device that received FDA 510(k) clearance on 2022-02-22. It is manufactured by Enbio Group AG. The 510(k) number is K213991.

When was Enbio S approved by the FDA?

Enbio S received FDA 510(k) clearance on 2022-02-22, under approval number K213991.

What company makes Enbio S?

Enbio S is manufactured by Enbio Group AG.

What is the FDA product code for Enbio S?

The FDA product code for Enbio S is FLE.

Other Devices by Enbio Group AG

K210279Enbio S K260254Enbio PRO

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K151597Family of Steam Sterilizers B 28 seriesCefla S.C. K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerMidmark Corporation K170228Belimed Steam Sterilizer MST-H TOP 5000Belimed AG K161848Family of Steam sterilizers B17 B22 SeriesCefla S.C. K180272Saniclave 250Revolutionary Science K172825MN-111W&H Sterilization S.R.L.

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.

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