FDA 510(k)

低血壓決策輔助

K 號：K190955 · 2019-11-27

決定日期2019-11-27

產品代碼DXG

諮詢委員會履歷

決定相當於

器材摘要

Hypotension Decision Assist is the device name listed in this FDA 510(k) record. The listed applicant is Directed Systems, Ltd.. It received FDA 510(k) clearance on 2019-11-27 under 510(k) number K190955. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hypotension Decision Assist?

Hypotension Decision Assist is a medical device that received FDA 510(k) clearance on 2019-11-27. The listed applicant is Directed Systems, Ltd.. The 510(k) number is K190955.

When did Hypotension Decision Assist receive FDA 510(k) clearance?

Hypotension Decision Assist received FDA 510(k) clearance on 2019-11-27, under 510(k) number K190955.

Who is the listed applicant for Hypotension Decision Assist?

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

What is the FDA product code for Hypotension Decision Assist?

The FDA product code for Hypotension Decision Assist is DXG.

其他以 Directed Systems, Ltd. 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。

K212529低血壓決策輔助模型 HDA-OR2

相關器械（代碼：DXG）

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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