FDA 510(k)

MT One 鑽石

K 號：K191942 · 2019-10-17

決定日期2019-10-17

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 Diamond 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 2019-10-17 under 510(k) number K191942. 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 Diamond?

MT One Diamond is a medical device that received FDA 510(k) clearance on 2019-10-17. The listed applicant is M&T S.R.L.. The 510(k) number is K191942.

When did MT One Diamond receive FDA 510(k) clearance?

MT One Diamond received FDA 510(k) clearance on 2019-10-17, under 510(k) number K191942.

Who is the listed applicant for MT One Diamond?

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 Diamond?

The FDA product code for MT One Diamond 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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K240604MTONE EVO (MTONE EVO)K192856MT One K172413MT 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。

相關器械（代碼：GEX）

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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官方來源

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