FDA 510(k)

美国 450 二极管激光设备

K号: K222916 · 2022-12-09

申请人Beijing Globalipl Development Co., Ltd.

决定日期2022-12-09

产品代码GEX

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决定实质等同

器械摘要

US 450 Diode Laser Equipment is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Globalipl Development Co., Ltd.. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K222916. 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 US 450 Diode Laser Equipment?

US 450 Diode Laser Equipment is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Beijing Globalipl Development Co., Ltd.. The 510(k) number is K222916.

When did US 450 Diode Laser Equipment receive FDA 510(k) clearance?

US 450 Diode Laser Equipment received FDA 510(k) clearance on 2022-12-09, under 510(k) number K222916.

Who is the listed applicant for US 450 Diode Laser Equipment?

The FDA 510(k) record lists Beijing Globalipl Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for US 450 Diode Laser Equipment?

The FDA product code for US 450 Diode Laser Equipment is GEX. This falls under the Gastroenterology category.

列明Beijing Globalipl Development 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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