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)

EndoTool SubQ

K 號:K180366 · 2018-09-20

決定日期2018-09-20
產品代碼NDC
諮詢委員會AN
決定相當於

器材摘要

EndoTool SubQ is the device name listed in this FDA 510(k) record. The listed applicant is Al Pacheco and Associates. It received FDA 510(k) clearance on 2018-09-20 under 510(k) number K180366. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EndoTool SubQ?

EndoTool SubQ is a medical device that received FDA 510(k) clearance on 2018-09-20. The listed applicant is Al Pacheco and Associates. The 510(k) number is K180366.

When did EndoTool SubQ receive FDA 510(k) clearance?

EndoTool SubQ received FDA 510(k) clearance on 2018-09-20, under 510(k) number K180366.

Who is the listed applicant for EndoTool SubQ?

The FDA 510(k) record lists Al Pacheco and Associates as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoTool SubQ?

The FDA product code for EndoTool SubQ is NDC.

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。

相關器械(代碼:NDC)

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。

↑