FDA 510(k)

LED光疗设备，KN-7000L

K号: K222751 · 2023-02-01

申请人Xuzhou Kernel Medical Equipment Co., Ltd.

决定日期2023-02-01

产品代码GEX

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决定实质等同

器械摘要

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.

常见问题

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)记录将徐州核芯医疗设备股份有限公司列为申请人。这本身并不能确立该设备制造商的身份。

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.

列明Xuzhou Kernel Medical Equipment Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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