免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

PlasmaBlade X 3.0S 輕型

K 號:K193579 · 2020-03-24

決定日期2020-03-24
產品代碼GEI
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

PlasmaBlade X 3.0S LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation. It received FDA 510(k) clearance on 2020-03-24 under 510(k) number K193579. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PlasmaBlade X 3.0S LIGHT?

PlasmaBlade X 3.0S LIGHT is a medical device that received FDA 510(k) clearance on 2020-03-24. The listed applicant is Medtronic Navigation. The 510(k) number is K193579.

When did PlasmaBlade X 3.0S LIGHT receive FDA 510(k) clearance?

PlasmaBlade X 3.0S LIGHT received FDA 510(k) clearance on 2020-03-24, under 510(k) number K193579.

Who is the listed applicant for PlasmaBlade X 3.0S LIGHT?

The FDA 510(k) record lists Medtronic Navigation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PlasmaBlade X 3.0S LIGHT?

The FDA product code for PlasmaBlade X 3.0S LIGHT is GEI.

相關臨床試驗

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。

其他以 Medtronic Navigation 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。

查看所有 9 項裝置 →

相關器械(代碼:GEI)

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

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。

↑