FDA 510(k)

TRIO 手柄

K 號：K183199 · 2019-05-02

決定日期2019-05-02

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

TRIO Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Omniguide, Inc.. It received FDA 510(k) clearance on 2019-05-02 under 510(k) number K183199. 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 TRIO Handpiece?

TRIO Handpiece is a medical device that received FDA 510(k) clearance on 2019-05-02. The listed applicant is Omniguide, Inc.. The 510(k) number is K183199.

When did TRIO Handpiece receive FDA 510(k) clearance?

TRIO Handpiece received FDA 510(k) clearance on 2019-05-02, under 510(k) number K183199.

Who is the listed applicant for TRIO Handpiece?

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

What is the FDA product code for TRIO Handpiece?

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

其他以 Omniguide, Inc. 為申請人之記錄

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