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FDA 510(k)

UDE

K-Number: K202292 · 2020-10-05

ApplicantEbm Technologies, Inc.
Decision Date2020-10-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UDE is a medical device manufactured by Ebm Technologies, Inc.. It received FDA 510(k) clearance on 2020-10-05 under approval number K202292. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UDE?

UDE is a medical device that received FDA 510(k) clearance on 2020-10-05. It is manufactured by Ebm Technologies, Inc.. The 510(k) number is K202292.

When was UDE approved by the FDA?

UDE received FDA 510(k) clearance on 2020-10-05, under approval number K202292.

What company makes UDE?

UDE is manufactured by Ebm Technologies, Inc..

What is the FDA product code for UDE?

The FDA product code for UDE is LLZ.

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Official Source

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