FDA 510(k)

UDE

K 號：K202292 · 2020-10-05

決定日期2020-10-05

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：LLZ）

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器材摘要

常見問題

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相關器械（代碼：LLZ）

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