FDA 510(k)

xeo+ 家族

K 號：K233237 · 2023-12-15

決定日期2023-12-15

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

xeo+ Family is the device name listed in this FDA 510(k) record. The listed applicant is Cutera, Inc.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K233237. 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 xeo+ Family?

xeo+ Family is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Cutera, Inc.. The 510(k) number is K233237.

When did xeo+ Family receive FDA 510(k) clearance?

xeo+ Family received FDA 510(k) clearance on 2023-12-15, under 510(k) number K233237.

Who is the listed applicant for xeo+ Family?

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

What is the FDA product code for xeo+ Family?

The FDA product code for xeo+ Family is GEX. This falls under the Gastroenterology category.

其他以 Cutera, Inc. 為申請人之記錄

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