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FDA 510(k)

eCARTv5臨床病情惡化套件（“eCART”）

K 號：K233253 · 2024-06-21

申請人Agilemd, Inc.
決定日期2024-06-21
產品代碼QNL
諮詢委員會履歷
決定相當於

器材摘要

eCARTv5 Clinical Deterioration Suite (“eCART”) is the device name listed in this FDA 510(k) record. The listed applicant is Agilemd, Inc.. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K233253. The device is classified under product code QNL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the eCARTv5 Clinical Deterioration Suite (“eCART”)?

eCARTv5 Clinical Deterioration Suite (“eCART”) is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Agilemd, Inc.. The 510(k) number is K233253.

When did eCARTv5 Clinical Deterioration Suite (“eCART”) receive FDA 510(k) clearance?

eCARTv5 Clinical Deterioration Suite (“eCART”) received FDA 510(k) clearance on 2024-06-21, under 510(k) number K233253.

Who is the listed applicant for eCARTv5 Clinical Deterioration Suite (“eCART”)?

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

What is the FDA product code for eCARTv5 Clinical Deterioration Suite (“eCART”)?

The FDA product code for eCARTv5 Clinical Deterioration Suite (“eCART”) is QNL.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：QNL）

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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