FDA 510(k)

Belimed Steam Sterilizer MST-H TOP 5000

K-Number: K191896 · 2019-10-31

Decision Date2019-10-31

Product CodeFLE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Belimed Steam Sterilizer MST-H TOP 5000 is a medical device manufactured by Belimed AG. It received FDA 510(k) clearance on 2019-10-31 under approval number K191896. 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 Belimed Steam Sterilizer MST-H TOP 5000?

Belimed Steam Sterilizer MST-H TOP 5000 is a medical device that received FDA 510(k) clearance on 2019-10-31. It is manufactured by Belimed AG. The 510(k) number is K191896.

When was Belimed Steam Sterilizer MST-H TOP 5000 approved by the FDA?

Belimed Steam Sterilizer MST-H TOP 5000 received FDA 510(k) clearance on 2019-10-31, under approval number K191896.

What company makes Belimed Steam Sterilizer MST-H TOP 5000?

Belimed Steam Sterilizer MST-H TOP 5000 is manufactured by Belimed AG.

What is the FDA product code for Belimed Steam Sterilizer MST-H TOP 5000?

The FDA product code for Belimed Steam Sterilizer MST-H TOP 5000 is FLE.

Other Devices by Belimed AG

K170228Belimed Steam Sterilizer MST-H TOP 5000

Related Devices (Code: FLE)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.