FDA 510(k)

低血壓決策輔助模型 HDA-OR2

K 號：K212529 · 2021-11-23

決定日期2021-11-23

產品代碼DXG

諮詢委員會履歷

決定相當於

器材摘要

Hypotension Decision Assist Model HDA-OR2 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 2021-11-23 under 510(k) number K212529. 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 Model HDA-OR2?

Hypotension Decision Assist Model HDA-OR2 is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Directed Systems, Ltd.. The 510(k) number is K212529.

When did Hypotension Decision Assist Model HDA-OR2 receive FDA 510(k) clearance?

Hypotension Decision Assist Model HDA-OR2 received FDA 510(k) clearance on 2021-11-23, under 510(k) number K212529.

Who is the listed applicant for Hypotension Decision Assist Model HDA-OR2?

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 Model HDA-OR2?

The FDA product code for Hypotension Decision Assist Model HDA-OR2 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。

K190955低血壓決策輔助

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。

K253092Argos Infinity (修訂版 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker Medical K232048科傑恩™ 靜脈血動監測系統；科傑恩™ HMSIcu Medical K192169PulsioFlex 監控系統搭配 ProAQT 传感器Pulsion Medical Systems SE K193179EV1000臨床平台Edwards Lifesciences, LLC K190955低血壓決策輔助Directed Systems, Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。