FDA 510(k)

Finapres Nova 非侵入式血流動力學監測儀

K 號：K160967 · 2017-04-18

決定日期2017-04-18

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Finapres Nova Noninvasive Hemodynamic Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Finapres Medical Systems B.V.. It received FDA 510(k) clearance on 2017-04-18 under 510(k) number K160967. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Finapres Nova Noninvasive Hemodynamic Monitor?

Finapres Nova Noninvasive Hemodynamic Monitor is a medical device that received FDA 510(k) clearance on 2017-04-18. The listed applicant is Finapres Medical Systems B.V.. The 510(k) number is K160967.

When did Finapres Nova Noninvasive Hemodynamic Monitor receive FDA 510(k) clearance?

Finapres Nova Noninvasive Hemodynamic Monitor received FDA 510(k) clearance on 2017-04-18, under 510(k) number K160967.

Who is the listed applicant for Finapres Nova Noninvasive Hemodynamic Monitor?

The FDA 510(k) record lists Finapres Medical Systems B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Finapres Nova Noninvasive Hemodynamic Monitor?

The FDA product code for Finapres Nova Noninvasive Hemodynamic Monitor is DXN.

其他以 Finapres Medical Systems B.V. 為申請人之記錄

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K173916Finapres Nova 非侵入式血流動力學監測儀

相關器械（代碼：DXN）

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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