FDA 510(k)

Epildream HP 4000 医療設備議定文

K 號：K222352 · 2023-04-27

決定日期2023-04-27

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：GEX）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：GEX）

官方來源