FDA 510(k)

UDE

K-Number: K202292 · 2020-10-05

Decision Date2020-10-05

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

UDE is the device name listed in this FDA 510(k) record. The listed applicant is Ebm Technologies, Inc.. It received FDA 510(k) clearance on 2020-10-05 under 510(k) 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. The listed applicant is Ebm Technologies, Inc.. The 510(k) number is K202292.

When did UDE receive FDA 510(k) clearance?

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

Who is the listed applicant for UDE?

The FDA 510(k) record lists Ebm Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UDE?

The FDA product code for UDE is LLZ.

Other records listing Ebm Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162285EBM iDO Viewer 1.2.1

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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.