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FDA 510(k)

Aluna 2

K 號：K232588 · 2024-11-25

申請人Knox Medical Diagnostics
決定日期2024-11-25
產品代碼BZH
諮詢委員會AN
決定相當於

器材摘要

Aluna 2 is the device name listed in this FDA 510(k) record. The listed applicant is Knox Medical Diagnostics. It received FDA 510(k) clearance on 2024-11-25 under 510(k) number K232588. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aluna 2?

Aluna 2 is a medical device that received FDA 510(k) clearance on 2024-11-25. The listed applicant is Knox Medical Diagnostics. The 510(k) number is K232588.

When did Aluna 2 receive FDA 510(k) clearance?

Aluna 2 received FDA 510(k) clearance on 2024-11-25, under 510(k) number K232588.

Who is the listed applicant for Aluna 2?

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

What is the FDA product code for Aluna 2?

The FDA product code for Aluna 2 is BZH.

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：BZH）

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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