FDA 510(k)

グローバルメディカルシステムズマイルズマンコンパクトレーザー

K番号: K203804 · 2021-02-23

決定日2021-02-23

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

Global Med Systems Milesman Compact Laser is the device name listed in this FDA 510(k) record. The listed applicant is Global Med Systems SL. It received FDA 510(k) clearance on 2021-02-23 under 510(k) number K203804. 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 Global Med Systems Milesman Compact Laser?

Global Med Systems Milesman Compact Laser is a medical device that received FDA 510(k) clearance on 2021-02-23. The listed applicant is Global Med Systems SL. The 510(k) number is K203804.

When did Global Med Systems Milesman Compact Laser receive FDA 510(k) clearance?

Global Med Systems Milesman Compact Laser received FDA 510(k) clearance on 2021-02-23, under 510(k) number K203804.

Who is the listed applicant for Global Med Systems Milesman Compact Laser?

The FDA 510(k) record lists Global Med Systems SL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Global Med Systems Milesman Compact Laser?

The FDA product code for Global Med Systems Milesman Compact Laser is GEX. This falls under the Gastroenterology category.

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グローバルメディカルシステムズマイルズマンコンパクトレーザー

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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