FDA 510(k)

Ezra Plexo 軟體

K 號：K192969 · 2020-07-10

決定日期2020-07-10

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Ezra Plexo Software is the device name listed in this FDA 510(k) record. The listed applicant is Ezra Ai, Inc.. It received FDA 510(k) clearance on 2020-07-10 under 510(k) number K192969. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ezra Plexo Software?

Ezra Plexo Software is a medical device that received FDA 510(k) clearance on 2020-07-10. The listed applicant is Ezra Ai, Inc.. The 510(k) number is K192969.

When did Ezra Plexo Software receive FDA 510(k) clearance?

Ezra Plexo Software received FDA 510(k) clearance on 2020-07-10, under 510(k) number K192969.

Who is the listed applicant for Ezra Plexo Software?

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

What is the FDA product code for Ezra Plexo Software?

The FDA product code for Ezra Plexo Software is QIH.

其他以 Ezra Ai, Inc. 為申請人之記錄

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相關器械（代碼：QIH）

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