FDA 510(k)

レーザーダイオードシステム

K番号: K181019 · 2018-07-16

申請者Guangzhou Huafei Tongda Technology Co., Ltd.

決定日2018-07-16

製品コードGEX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Diode Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Huafei Tongda Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-07-16 under 510(k) number K181019. 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.

よくある質問

What is the Diode Laser System?

Diode Laser System is a medical device that received FDA 510(k) clearance on 2018-07-16. The listed applicant is Guangzhou Huafei Tongda Technology Co., Ltd.. The 510(k) number is K181019.

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

Diode Laser System received FDA 510(k) clearance on 2018-07-16, under 510(k) number K181019.

Who is the listed applicant for Diode Laser System?

The FDA 510(k) record lists Guangzhou Huafei Tongda Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode Laser System?

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

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レーザーダイオードシステム

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GEX）

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