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FDA 510(k)

Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers

K-Number: K170304 · 2018-03-02

ApplicantAstell Scientific Limited
Decision Date2018-03-02
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers is a medical device manufactured by Astell Scientific Limited. It received FDA 510(k) clearance on 2018-03-02 under approval number K170304. 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 Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers?

Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers is a medical device that received FDA 510(k) clearance on 2018-03-02. It is manufactured by Astell Scientific Limited. The 510(k) number is K170304.

When was Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers approved by the FDA?

Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers received FDA 510(k) clearance on 2018-03-02, under approval number K170304.

What company makes Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers?

Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers is manufactured by Astell Scientific Limited.

What is the FDA product code for Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers?

The FDA product code for Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers is FLE.

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

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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