FDA 510(k)

二極雷射系統 GP900A8，二極雷射系統 GP900Q8

K 號：K213225 · 2021-12-22

決定日期2021-12-22

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

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.

常見問題

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.

其他以 Shenzhen Gsd Tech Co., Ltd. 為申請人之記錄

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官方來源

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