FDA 510(k)

EchoGo 心衰竭

K 號：K222463 · 2022-11-23

決定日期2022-11-23

產品代碼QUO

諮詢委員會履歷

決定相當於

器材摘要

EchoGo Heart Failure is the device name listed in this FDA 510(k) record. The listed applicant is Ultromics Limited. It received FDA 510(k) clearance on 2022-11-23 under 510(k) number K222463. The device is classified under product code QUO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EchoGo Heart Failure?

EchoGo Heart Failure is a medical device that received FDA 510(k) clearance on 2022-11-23. The listed applicant is Ultromics Limited. The 510(k) number is K222463.

When did EchoGo Heart Failure receive FDA 510(k) clearance?

EchoGo Heart Failure received FDA 510(k) clearance on 2022-11-23, under 510(k) number K222463.

Who is the listed applicant for EchoGo Heart Failure?

The FDA 510(k) record lists Ultromics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EchoGo Heart Failure?

The FDA product code for EchoGo Heart Failure is QUO.

其他以 Ultromics Limited 為申請人之記錄

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。

K240860EchoGo 阿米洛德症（1.0）K240013EchoGo 心衰竭 (2.0)K213275EchoGo Core (2.0)

相關器械（代碼：QUO）

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。

K251293心視覺 CardioVisionIcardio.Ai K240013EchoGo 心衰竭 (2.0)Ultromics Limited K223905維沃® LVEDP 系統Avicena, LLC

官方來源

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