FDA 510(k)

PreSep 過氧濃度測量導管

K 號：K160645 · 2016-06-16

決定日期2016-06-16

產品代碼DQE

諮詢委員會履歷

決定相當於

器材摘要

PreSep Oligon Oximetry Catheter 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 2016-06-16 under 510(k) number K160645. The device is classified under product code DQE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PreSep Oligon Oximetry Catheter?

PreSep Oligon Oximetry Catheter is a medical device that received FDA 510(k) clearance on 2016-06-16. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K160645.

When did PreSep Oligon Oximetry Catheter receive FDA 510(k) clearance?

PreSep Oligon Oximetry Catheter received FDA 510(k) clearance on 2016-06-16, under 510(k) number K160645.

Who is the listed applicant for PreSep Oligon Oximetry Catheter?

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 PreSep Oligon Oximetry Catheter?

The FDA product code for PreSep Oligon Oximetry Catheter is DQE.

其他以 Edwards Lifesciences, LLC 為申請人之記錄

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相關器械（代碼：DQE）

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。

K172423PediaSat 氧氣濃度導管，PreSep Oligon 氧氣濃度導管，Edwards 氧氣濃度中心靜脈導管（之前為 PreSep 氧氣濃度導管）Edwards Lifescience, LLC

官方來源

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