FDA 510(k)

Eneka Pro

K 號：K223680 · 2023-02-10

決定日期2023-02-10

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

Eneka Pro is the device name listed in this FDA 510(k) record. The listed applicant is Termosalud. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K223680. 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 Eneka Pro?

Eneka Pro is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Termosalud. The 510(k) number is K223680.

When did Eneka Pro receive FDA 510(k) clearance?

Eneka Pro received FDA 510(k) clearance on 2023-02-10, under 510(k) number K223680.

Who is the listed applicant for Eneka Pro?

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

What is the FDA product code for Eneka Pro?

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

其他以 Termosalud 為申請人之記錄

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官方來源

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