FDA 510(k)

EndoTool SubQ 2.1

K 號：K211160 · 2021-10-28

決定日期2021-10-28

產品代碼NDC

諮詢委員會AN

決定相當於

器材摘要

EndoTool SubQ 2.1 is the device name listed in this FDA 510(k) record. The listed applicant is Monarch Medical Technologies, LLC. It received FDA 510(k) clearance on 2021-10-28 under 510(k) number K211160. 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 2.1?

EndoTool SubQ 2.1 is a medical device that received FDA 510(k) clearance on 2021-10-28. The listed applicant is Monarch Medical Technologies, LLC. The 510(k) number is K211160.

When did EndoTool SubQ 2.1 receive FDA 510(k) clearance?

EndoTool SubQ 2.1 received FDA 510(k) clearance on 2021-10-28, under 510(k) number K211160.

Who is the listed applicant for EndoTool SubQ 2.1?

The FDA 510(k) record lists Monarch Medical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoTool SubQ 2.1?

The FDA product code for EndoTool SubQ 2.1 is NDC.

其他以 Monarch Medical Technologies, LLC 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。

K201619EndoTool IV系統 K200443EndoTool IV 1.10

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。

K254102GlucommanderGlytec, LLC K260910EndoTool IV雲端 1.0Glooko, Inc.K253512迷你美迪 Go AppMedtronic Minimed K253281上醫材Updoc, Inc.K252104T1D1Comerge AG K241088EndoTool IV (3.1)Monarch Medical Technologies

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。