FDA 510(k)

REMI-AI 快速檢測模組（REMI-AI RDM）

K 號：K240408 · 2024-10-17

決定日期2024-10-17

產品代碼OMB

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

REMI-AI Rapid Detection Module (REMI-AI RDM) is the device name listed in this FDA 510(k) record. The listed applicant is Epitel, Inc.. It received FDA 510(k) clearance on 2024-10-17 under 510(k) number K240408. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the REMI-AI Rapid Detection Module (REMI-AI RDM)?

REMI-AI Rapid Detection Module (REMI-AI RDM) is a medical device that received FDA 510(k) clearance on 2024-10-17. The listed applicant is Epitel, Inc.. The 510(k) number is K240408.

When did REMI-AI Rapid Detection Module (REMI-AI RDM) receive FDA 510(k) clearance?

REMI-AI Rapid Detection Module (REMI-AI RDM) received FDA 510(k) clearance on 2024-10-17, under 510(k) number K240408.

Who is the listed applicant for REMI-AI Rapid Detection Module (REMI-AI RDM)?

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

What is the FDA product code for REMI-AI Rapid Detection Module (REMI-AI RDM)?

The FDA product code for REMI-AI Rapid Detection Module (REMI-AI RDM) is OMB.

其他以 Epitel, Inc. 為申請人之記錄

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相關器械（代碼：OMB）

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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