FDA 510(k)

BC-5

K 號：K191693 · 2019-11-01

決定日期2019-11-01

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

BC-5 is the device name listed in this FDA 510(k) record. The listed applicant is Reveallux, Corp. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K191693. 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 BC-5?

BC-5 is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Reveallux, Corp. The 510(k) number is K191693.

When did BC-5 receive FDA 510(k) clearance?

BC-5 received FDA 510(k) clearance on 2019-11-01, under 510(k) number K191693.

Who is the listed applicant for BC-5?

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

What is the FDA product code for BC-5?

The FDA product code for BC-5 is GEX. This falls under the Gastroenterology category.

相關器械（代碼：GEX）

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