FDA 510(k)

eCare協調員

K 號：K171029 · 2017-07-14

決定日期2017-07-14

產品代碼DRG

諮詢委員會履歷

決定相當於

器材摘要

eCareCoordinator is the device name listed in this FDA 510(k) record. The listed applicant is Visicu, Inc.. It received FDA 510(k) clearance on 2017-07-14 under 510(k) number K171029. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the eCareCoordinator?

eCareCoordinator is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Visicu, Inc.. The 510(k) number is K171029.

When did eCareCoordinator receive FDA 510(k) clearance?

eCareCoordinator received FDA 510(k) clearance on 2017-07-14, under 510(k) number K171029.

Who is the listed applicant for eCareCoordinator?

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

What is the FDA product code for eCareCoordinator?

The FDA product code for eCareCoordinator is DRG.

其他以 Visicu, 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。

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相關器械（代碼：DRG）

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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官方來源

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