FDA 510(k)

DyeVert Plus 藍光調節/監測系統，藍光監測系統

K 號：K163054 · 2017-03-08

決定日期2017-03-08

產品代碼DXT

諮詢委員會履歷

決定相當於

器材摘要

DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Osprey Medical, Inc.. It received FDA 510(k) clearance on 2017-03-08 under 510(k) number K163054. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System?

DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System is a medical device that received FDA 510(k) clearance on 2017-03-08. The listed applicant is Osprey Medical, Inc.. The 510(k) number is K163054.

When did DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System receive FDA 510(k) clearance?

DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System received FDA 510(k) clearance on 2017-03-08, under 510(k) number K163054.

Who is the listed applicant for DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System?

The FDA 510(k) record lists Osprey Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System?

The FDA product code for DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System is DXT.

其他以 Osprey Medical, Inc. 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。

K190102DyeVert™ Plus 預染減影系統，DyeTect™ 預染監測系統，DyeVert™ Plus EZ 預染減影系統 K183267DyeVert™ NG 藍光減少系統，DyeVert™ PLUS EZ 藍光減少系統，DyeTect™ 藍光監測一次性套件，智慧針筒，DyeVert™ PLUS EZ 藍光減少系統 K181936染綠 PLUS 輕鬆對比減少系統 K171698智慧針筒 K171217染綠 Plus 預測對比減少系統，染綠 NG 預測對比減少系統 K161505染綠NG對比調節系統

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相關器械（代碼：DXT）

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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