FDA 510(k)

CDI OneView 監控系統

K 號：K234065 · 2024-04-25

申請人Terumo Cardiovascular Systems Corporation

決定日期2024-04-25

產品代碼DRY

諮詢委員會履歷

決定相當於

器材摘要

CDI OneView Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2024-04-25 under 510(k) number K234065. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CDI OneView Monitoring System?

CDI OneView Monitoring System is a medical device that received FDA 510(k) clearance on 2024-04-25. The listed applicant is Terumo Cardiovascular Systems Corporation. The 510(k) number is K234065.

When did CDI OneView Monitoring System receive FDA 510(k) clearance?

CDI OneView Monitoring System received FDA 510(k) clearance on 2024-04-25, under 510(k) number K234065.

Who is the listed applicant for CDI OneView Monitoring System?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CDI OneView Monitoring System?

The FDA product code for CDI OneView Monitoring System is DRY.

其他以 Terumo Cardiovascular Systems Corporation 為申請人之記錄

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相關器械（代碼：DRY）

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。

K202154B-CaptaLivanova Deutschland, GmbH K202557量子工作站 12 精英Spectrum Medical , Ltd.K182110CDI 血液參數監測系統 550Terumo Cardiovascular Systems Corporation K181923量子工作站 12.1Spectrum Medical , Ltd.K173591量子診斷模組，量子診斷模組 - 不含氣體Spectrum Medical , Ltd.K163657量子工作站Spectrum Medical , Ltd.

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