FDA 510(k)

eCareManager 4.0.1

K 號：K153156 · 2016-09-30

決定日期2016-09-30

產品代碼MSX

諮詢委員會履歷

決定相當於

器材摘要

eCareManager 4.0.1 is the device name listed in this FDA 510(k) record. The listed applicant is Visicu, Inc.. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K153156. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the eCareManager 4.0.1?

eCareManager 4.0.1 is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Visicu, Inc.. The 510(k) number is K153156.

When did eCareManager 4.0.1 receive FDA 510(k) clearance?

eCareManager 4.0.1 received FDA 510(k) clearance on 2016-09-30, under 510(k) number K153156.

Who is the listed applicant for eCareManager 4.0.1?

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 eCareManager 4.0.1?

The FDA product code for eCareManager 4.0.1 is MSX.

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。

K211046eCareManager 4.5 K171322eCareManager 4.1 K171029eCare協調員

相關器械（代碼：MSX）

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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