FDA 510(k)

MT ONE 醫療設備規範文本翻譯： MT ONE 注意事項：保留公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址。政策：醫療規範-v1。僅返回翻譯內容。

K 號：K172413 · 2017-10-06

決定日期2017-10-06

產品代碼GEX

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

MT ONE is the device name listed in this FDA 510(k) record. The listed applicant is M&T S.R.L.. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K172413. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the MT ONE?

MT ONE is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is M&T S.R.L.. The 510(k) number is K172413.

When did MT ONE receive FDA 510(k) clearance?

MT ONE received FDA 510(k) clearance on 2017-10-06, under 510(k) number K172413.

Who is the listed applicant for MT ONE?

The FDA 510(k) record lists M&T S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MT ONE?

The FDA product code for MT ONE is GEX. This falls under the Gastroenterology category.

其他以 M&T S.R.L. 為申請人之記錄

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官方來源

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