FDA 510(k)

AMSCO 600 Steam Sterilizer

K-Number: K183410 · 2019-03-27

Decision Date2019-03-27

Product CodeFLE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

AMSCO 600 Steam Sterilizer is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2019-03-27 under approval number K183410. 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 AMSCO 600 Steam Sterilizer?

AMSCO 600 Steam Sterilizer is a medical device that received FDA 510(k) clearance on 2019-03-27. It is manufactured by STERIS Corporation. The 510(k) number is K183410.

When was AMSCO 600 Steam Sterilizer approved by the FDA?

AMSCO 600 Steam Sterilizer received FDA 510(k) clearance on 2019-03-27, under approval number K183410.

What company makes AMSCO 600 Steam Sterilizer?

AMSCO 600 Steam Sterilizer is manufactured by STERIS Corporation.

What is the FDA product code for AMSCO 600 Steam Sterilizer?

The FDA product code for AMSCO 600 Steam Sterilizer is FLE.

Other Devices by STERIS Corporation

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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.