FDA 510(k)

LED光療設備，KN-7000L

K 號：K222751 · 2023-02-01

申請人Xuzhou Kernel Medical Equipment Co., Ltd.

決定日期2023-02-01

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

LED Light Therapy Device, KN-7000L is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-02-01 under 510(k) number K222751. 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 LED Light Therapy Device, KN-7000L?

LED Light Therapy Device, KN-7000L is a medical device that received FDA 510(k) clearance on 2023-02-01. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K222751.

When did LED Light Therapy Device, KN-7000L receive FDA 510(k) clearance?

LED Light Therapy Device, KN-7000L received FDA 510(k) clearance on 2023-02-01, under 510(k) number K222751.

Who is the listed applicant for LED Light Therapy Device, KN-7000L?

FDA 510(k) 記錄將徐州核子醫療設備有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for LED Light Therapy Device, KN-7000L?

The FDA product code for LED Light Therapy Device, KN-7000L is GEX. This falls under the Gastroenterology category.

其他以 Xuzhou Kernel Medical Equipment Co., Ltd. 為申請人之記錄

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