FDA 510(k)

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K 號：K210951 · 2021-09-01

決定日期2021-09-01

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

Leonardo Mini Blue is the device name listed in this FDA 510(k) record. The listed applicant is Ceramoptec GmbH. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K210951. 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 Leonardo Mini Blue?

Leonardo Mini Blue is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is Ceramoptec GmbH. The 510(k) number is K210951.

When did Leonardo Mini Blue receive FDA 510(k) clearance?

Leonardo Mini Blue received FDA 510(k) clearance on 2021-09-01, under 510(k) number K210951.

Who is the listed applicant for Leonardo Mini Blue?

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

What is the FDA product code for Leonardo Mini Blue?

The FDA product code for Leonardo Mini Blue is GEX. This falls under the Gastroenterology category.

其他以 Ceramoptec GmbH 為申請人之記錄

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官方來源

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