FDA 510(k)

纖維搭DX

K 號：K172612 · 2017-09-28

決定日期2017-09-28

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

FiberTak DX is the device name listed in this FDA 510(k) record. The listed applicant is Arthex, Inc.. It received FDA 510(k) clearance on 2017-09-28 under 510(k) number K172612. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FiberTak DX?

FiberTak DX is a medical device that received FDA 510(k) clearance on 2017-09-28. The listed applicant is Arthex, Inc.. The 510(k) number is K172612.

When did FiberTak DX receive FDA 510(k) clearance?

FiberTak DX received FDA 510(k) clearance on 2017-09-28, under 510(k) number K172612.

Who is the listed applicant for FiberTak DX?

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

What is the FDA product code for FiberTak DX?

The FDA product code for FiberTak DX is MBI.

其他以 Arthex, Inc. 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。

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相關器械（代碼：MBI）

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。

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