FDA 510(k)

全球低灌流指數（GHI）演算法

K 號：K231038 · 2023-07-26

決定日期2023-07-26

產品代碼QNL

諮詢委員會履歷

決定相當於

器材摘要

Global Hypoperfusion Index (GHI) Algorithm is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2023-07-26 under 510(k) number K231038. The device is classified under product code QNL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Global Hypoperfusion Index (GHI) Algorithm?

Global Hypoperfusion Index (GHI) Algorithm is a medical device that received FDA 510(k) clearance on 2023-07-26. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K231038.

When did Global Hypoperfusion Index (GHI) Algorithm receive FDA 510(k) clearance?

Global Hypoperfusion Index (GHI) Algorithm received FDA 510(k) clearance on 2023-07-26, under 510(k) number K231038.

Who is the listed applicant for Global Hypoperfusion Index (GHI) Algorithm?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Global Hypoperfusion Index (GHI) Algorithm?

The FDA product code for Global Hypoperfusion Index (GHI) Algorithm is QNL.

其他以 Edwards Lifesciences, LLC 為申請人之記錄

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相關器械（代碼：QNL）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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