FDA 510(k)

Alma ディオードテーブルトップレーザー

K番号: K160952 · 2016-05-05

決定日2016-05-05

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

Alma Diode Tabletop Laser is the device name listed in this FDA 510(k) record. The listed applicant is Alma, Ltd.. It received FDA 510(k) clearance on 2016-05-05 under 510(k) number K160952. 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 Alma Diode Tabletop Laser?

Alma Diode Tabletop Laser is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Alma, Ltd.. The 510(k) number is K160952.

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

Alma Diode Tabletop Laser received FDA 510(k) clearance on 2016-05-05, under 510(k) number K160952.

Who is the listed applicant for Alma Diode Tabletop Laser?

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

What is the FDA product code for Alma Diode Tabletop Laser?

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

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Alma ディオードテーブルトップレーザー

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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