FDA 510(k)

エピルドリーム HP 4000 メディカル

K番号: K222352 · 2023-04-27

決定日2023-04-27

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

Epildream HP 4000 MED is the device name listed in this FDA 510(k) record. The listed applicant is D.E.A Project S.R.1.. It received FDA 510(k) clearance on 2023-04-27 under 510(k) number K222352. 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 Epildream HP 4000 MED?

Epildream HP 4000 MED is a medical device that received FDA 510(k) clearance on 2023-04-27. The listed applicant is D.E.A Project S.R.1.. The 510(k) number is K222352.

When did Epildream HP 4000 MED receive FDA 510(k) clearance?

Epildream HP 4000 MED received FDA 510(k) clearance on 2023-04-27, under 510(k) number K222352.

Who is the listed applicant for Epildream HP 4000 MED?

The FDA 510(k) record lists D.E.A Project S.R.1. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Epildream HP 4000 MED?

The FDA product code for Epildream HP 4000 MED is GEX. This falls under the Gastroenterology category.

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。

エピルドリーム HP 4000 メディカル

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）

公式ソース