FDA 510(k)

二極雷射機，型號編號：BM-100

K 號：K211335 · 2021-07-28

決定日期2021-07-28

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 Machine, Model Number: BM-100 is the device name listed in this FDA 510(k) record. The listed applicant is Zhengzhou Bestview ST Co., Ltd.. It received FDA 510(k) clearance on 2021-07-28 under 510(k) number K211335. 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 Machine, Model Number: BM-100?

Diode Laser Machine, Model Number: BM-100 is a medical device that received FDA 510(k) clearance on 2021-07-28. The listed applicant is Zhengzhou Bestview ST Co., Ltd.. The 510(k) number is K211335.

When did Diode Laser Machine, Model Number: BM-100 receive FDA 510(k) clearance?

Diode Laser Machine, Model Number: BM-100 received FDA 510(k) clearance on 2021-07-28, under 510(k) number K211335.

Who is the listed applicant for Diode Laser Machine, Model Number: BM-100?

The FDA 510(k) record lists Zhengzhou Bestview ST Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode Laser Machine, Model Number: BM-100?

The FDA product code for Diode Laser Machine, Model Number: BM-100 is GEX. This falls under the Gastroenterology category.

其他以 Zhengzhou Bestview ST Co., Ltd. 為申請人之記錄

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