FDA 510(k)

Flo Trac感測器，體積視覺感測器

K 號：K152980 · 2016-01-19

決定日期2016-01-19

產品代碼DRS

諮詢委員會履歷

決定相當於

器材摘要

Flo Trac sensor, Volume View sensor 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 2016-01-19 under 510(k) number K152980. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Flo Trac sensor, Volume View sensor?

Flo Trac sensor, Volume View sensor is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K152980.

When did Flo Trac sensor, Volume View sensor receive FDA 510(k) clearance?

Flo Trac sensor, Volume View sensor received FDA 510(k) clearance on 2016-01-19, under 510(k) number K152980.

Who is the listed applicant for Flo Trac sensor, Volume View sensor?

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 Flo Trac sensor, Volume View sensor?

The FDA product code for Flo Trac sensor, Volume View sensor is DRS.

其他以 Edwards Lifesciences, LLC 為申請人之記錄

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相關器械（代碼：DRS）

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。

K254074真壓Procerus Enterprises K242909FloTrac感測器；FloTrac Jr感測器；Acumen IQ感測器；VolumeView感測器Edwards Lifesciences, LLC K221782Meritrans ECO 可重用壓力傳感器，Meritrans ECO 球帽Merit Medical Pte. , Ltd.K172458HemoDraw Plus 關閉式血液採樣系統搭配 LogiCal 轉換器套件，HemoDraw Plus 關閉式血液採樣系統搭配 Transtar 轉換器套件Smiths Medical Asd, Inc.K163172HemoDraw Plus 關閉式血液採樣系統搭配 LogiCal 轉換器套件，HemoDraw Plus 關閉式血液採樣系統搭配 Transtar 轉換器套件Smiths Medical Asd, Inc.K161408羅盤針與MAPCenturion Medical Products Corporation

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