FDA 510(k)

VUNO 医用胸腔X光分類/VUNO 医用CXR連結分類

K 號：K241439 · 2024-11-15

決定日期2024-11-15

產品代碼QFM

諮詢委員會RA

決定相當於

器材摘要

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is the device name listed in this FDA 510(k) record. The listed applicant is Vuno, Inc.. It received FDA 510(k) clearance on 2024-11-15 under 510(k) number K241439. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage?

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is a medical device that received FDA 510(k) clearance on 2024-11-15. The listed applicant is Vuno, Inc.. The 510(k) number is K241439.

When did VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage receive FDA 510(k) clearance?

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage received FDA 510(k) clearance on 2024-11-15, under 510(k) number K241439.

Who is the listed applicant for VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage?

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

What is the FDA product code for VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage?

The FDA product code for VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is QFM.

其他以 Vuno, Inc. 為申請人之記錄

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。

K231398VUNO 医療設備議定文

相關器械（代碼：QFM）

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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