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FDA 510(k)

Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000

K-Number: K173493 · 2018-02-23

ApplicantSTERIS Corporation
Decision Date2018-02-23
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2018-02-23 under approval number K173493. 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 Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000?

Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 is a medical device that received FDA 510(k) clearance on 2018-02-23. It is manufactured by STERIS Corporation. The 510(k) number is K173493.

When was Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 approved by the FDA?

Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 received FDA 510(k) clearance on 2018-02-23, under approval number K173493.

What company makes Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000?

Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 is manufactured by STERIS Corporation.

What is the FDA product code for Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000?

The FDA product code for Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 is FLE.

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Related Devices (Code: 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.

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