FDA 510(k)

EV1000臨床平台

K 號：K193179 · 2019-12-17

決定日期2019-12-17

產品代碼DXG

諮詢委員會履歷

決定相當於

器材摘要

EV1000 Clinical Platform 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 2019-12-17 under 510(k) number K193179. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EV1000 Clinical Platform?

EV1000 Clinical Platform is a medical device that received FDA 510(k) clearance on 2019-12-17. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K193179.

When did EV1000 Clinical Platform receive FDA 510(k) clearance?

EV1000 Clinical Platform received FDA 510(k) clearance on 2019-12-17, under 510(k) number K193179.

Who is the listed applicant for EV1000 Clinical Platform?

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 EV1000 Clinical Platform?

The FDA product code for EV1000 Clinical Platform is DXG.

其他以 Edwards Lifesciences, LLC 為申請人之記錄

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相關器械（代碼：DXG）

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。

K253092Argos Infinity (修訂版 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker Medical K232048科傑恩™ 靜脈血動監測系統；科傑恩™ HMSIcu Medical K212529低血壓決策輔助模型 HDA-OR2Directed Systems, Ltd.K192169PulsioFlex 監控系統搭配 ProAQT 传感器Pulsion Medical Systems SE K190955低血壓決策輔助Directed Systems, Ltd.

官方來源

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