FDA 510(k)

フレドー

K番号: K242132 · 2024-10-18

申請者Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda

決定日2024-10-18

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

FREDDO is the device name listed in this FDA 510(k) record. The listed applicant is Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K242132. 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 FREDDO?

FREDDO is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda. The 510(k) number is K242132.

When did FREDDO receive FDA 510(k) clearance?

FREDDO received FDA 510(k) clearance on 2024-10-18, under 510(k) number K242132.

Who is the listed applicant for FREDDO?

The FDA 510(k) record lists Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FREDDO?

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

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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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