FDA 510(k)

EndoTool IV系統

K 號：K201619 · 2020-08-07

決定日期2020-08-07

產品代碼NDC

諮詢委員會AN

決定相當於

器材摘要

EndoTool IV System 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 2020-08-07 under 510(k) number K201619. 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 IV System?

EndoTool IV System is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is Monarch Medical Technologies, LLC. The 510(k) number is K201619.

When did EndoTool IV System receive FDA 510(k) clearance?

EndoTool IV System received FDA 510(k) clearance on 2020-08-07, under 510(k) number K201619.

Who is the listed applicant for EndoTool IV System?

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 IV System?

The FDA product code for EndoTool IV System 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。

K211160EndoTool SubQ 2.1 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

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