FDA 510(k)

ライトフュージョンLEDシステム

K番号: K162556 · 2017-03-24

決定日2017-03-24

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

LIGHTFUSION LED SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vitage Led, Ltd.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K162556. 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 LIGHTFUSION LED SYSTEM?

LIGHTFUSION LED SYSTEM is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Vitage Led, Ltd.. The 510(k) number is K162556.

When did LIGHTFUSION LED SYSTEM receive FDA 510(k) clearance?

LIGHTFUSION LED SYSTEM received FDA 510(k) clearance on 2017-03-24, under 510(k) number K162556.

Who is the listed applicant for LIGHTFUSION LED SYSTEM?

The FDA 510(k) record lists Vitage Led, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIGHTFUSION LED SYSTEM?

The FDA product code for LIGHTFUSION LED SYSTEM is GEX. This falls under the Gastroenterology category.

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ライトフュージョンLED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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