FDA 510(k)

EpilME

K 號：K213261 · 2022-06-02

決定日期2022-06-02

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

EpilME is the device name listed in this FDA 510(k) record. The listed applicant is Neauvia North America. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K213261. 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 EpilME?

EpilME is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is Neauvia North America. The 510(k) number is K213261.

When did EpilME receive FDA 510(k) clearance?

EpilME received FDA 510(k) clearance on 2022-06-02, under 510(k) number K213261.

Who is the listed applicant for EpilME?

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

What is the FDA product code for EpilME?

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

其他以 Neauvia North America 為申請人之記錄

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相關器械（代碼：GEX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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