FDA 510(k)

ソリライトLG4ガリレオ

K番号: K192755 · 2019-12-20

決定日2019-12-20

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

Soli-Lite LG4 Galileo is the device name listed in this FDA 510(k) record. The listed applicant is Silhouet-Tone Corporation. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K192755. 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 Soli-Lite LG4 Galileo?

Soli-Lite LG4 Galileo is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Silhouet-Tone Corporation. The 510(k) number is K192755.

When did Soli-Lite LG4 Galileo receive FDA 510(k) clearance?

Soli-Lite LG4 Galileo received FDA 510(k) clearance on 2019-12-20, under 510(k) number K192755.

Who is the listed applicant for Soli-Lite LG4 Galileo?

The FDA 510(k) record lists Silhouet-Tone Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Soli-Lite LG4 Galileo?

The FDA product code for Soli-Lite LG4 Galileo is GEX. This falls under the Gastroenterology category.

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ソリライトLG4ガリレオ

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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