FDA 510(k)

ORskin ブルー

K番号: K232858 · 2024-05-01

決定日2024-05-01

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

ORskin Blue is the device name listed in this FDA 510(k) record. The listed applicant is Megabay S.A.. It received FDA 510(k) clearance on 2024-05-01 under 510(k) number K232858. 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 ORskin Blue?

ORskin Blue is a medical device that received FDA 510(k) clearance on 2024-05-01. The listed applicant is Megabay S.A.. The 510(k) number is K232858.

When did ORskin Blue receive FDA 510(k) clearance?

ORskin Blue received FDA 510(k) clearance on 2024-05-01, under 510(k) number K232858.

Who is the listed applicant for ORskin Blue?

The FDA 510(k) record lists Megabay S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORskin Blue?

The FDA product code for ORskin Blue is GEX. This falls under the Gastroenterology category.

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ORskin ブルー

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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