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FDA 510(k)

非侵入式血流動力血壓監測器

K 號:K190893 · 2019-08-07

決定日期2019-08-07
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

Non-invasive Hemodynamic Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Vita-Course Technologies Co., Ltd.. It received FDA 510(k) clearance on 2019-08-07 under 510(k) number K190893. 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 Non-invasive Hemodynamic Blood Pressure Monitor?

Non-invasive Hemodynamic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2019-08-07. The listed applicant is Vita-Course Technologies Co., Ltd.. The 510(k) number is K190893.

When did Non-invasive Hemodynamic Blood Pressure Monitor receive FDA 510(k) clearance?

Non-invasive Hemodynamic Blood Pressure Monitor received FDA 510(k) clearance on 2019-08-07, under 510(k) number K190893.

Who is the listed applicant for Non-invasive Hemodynamic Blood Pressure Monitor?

The FDA 510(k) record lists Vita-Course Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-invasive Hemodynamic Blood Pressure Monitor?

The FDA product code for Non-invasive Hemodynamic Blood Pressure Monitor is DXN.

相關臨床試驗

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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。

官方來源

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