FDA 510(k)

二极管激光系统 GP900A8，二极管激光系统 GP900Q8

K号: K213225 · 2021-12-22

决定日期2021-12-22

产品代码GEX

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决定实质等同

器械摘要

Diode Laser System GP900A8, Diode Laser System GP900Q8 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Gsd Tech Co., Ltd.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K213225. 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 Diode Laser System GP900A8, Diode Laser System GP900Q8?

Diode Laser System GP900A8, Diode Laser System GP900Q8 is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Shenzhen Gsd Tech Co., Ltd.. The 510(k) number is K213225.

When did Diode Laser System GP900A8, Diode Laser System GP900Q8 receive FDA 510(k) clearance?

Diode Laser System GP900A8, Diode Laser System GP900Q8 received FDA 510(k) clearance on 2021-12-22, under 510(k) number K213225.

Who is the listed applicant for Diode Laser System GP900A8, Diode Laser System GP900Q8?

The FDA 510(k) record lists Shenzhen Gsd Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode Laser System GP900A8, Diode Laser System GP900Q8?

The FDA product code for Diode Laser System GP900A8, Diode Laser System GP900Q8 is GEX. This falls under the Gastroenterology category.

列明Shenzhen Gsd Tech 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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