FDA 510(k)

MIIN

K 號：K193266 · 2021-01-22

決定日期2021-01-22

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

MIIN is the device name listed in this FDA 510(k) record. The listed applicant is Medico USA, Inc.. It received FDA 510(k) clearance on 2021-01-22 under 510(k) number K193266. 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 MIIN?

MIIN is a medical device that received FDA 510(k) clearance on 2021-01-22. The listed applicant is Medico USA, Inc.. The 510(k) number is K193266.

When did MIIN receive FDA 510(k) clearance?

MIIN received FDA 510(k) clearance on 2021-01-22, under 510(k) number K193266.

Who is the listed applicant for MIIN?

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

What is the FDA product code for MIIN?

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

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官方來源

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