FDA 510(k)

eCO2 3D

K 號：K244060 · 2025-07-31

決定日期2025-07-31

產品代碼ONG

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

eCO2 3D is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Corporation. It received FDA 510(k) clearance on 2025-07-31 under 510(k) number K244060. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the eCO2 3D?

eCO2 3D is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is Lutronic Corporation. The 510(k) number is K244060.

When did eCO2 3D receive FDA 510(k) clearance?

eCO2 3D received FDA 510(k) clearance on 2025-07-31, under 510(k) number K244060.

Who is the listed applicant for eCO2 3D?

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

What is the FDA product code for eCO2 3D?

The FDA product code for eCO2 3D is ONG.

其他以 Lutronic Corporation 為申請人之記錄

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相關器械（代碼：ONG）

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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