FDA 510(k)

肺Q 4

K 號：K250766 · 2025-10-02

決定日期2025-10-02

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

LungQ 4 is the device name listed in this FDA 510(k) record. The listed applicant is Thirona BV. It received FDA 510(k) clearance on 2025-10-02 under 510(k) number K250766. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LungQ 4?

LungQ 4 is a medical device that received FDA 510(k) clearance on 2025-10-02. The listed applicant is Thirona BV. The 510(k) number is K250766.

When did LungQ 4 receive FDA 510(k) clearance?

LungQ 4 received FDA 510(k) clearance on 2025-10-02, under 510(k) number K250766.

Who is the listed applicant for LungQ 4?

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

What is the FDA product code for LungQ 4?

The FDA product code for LungQ 4 is JAK.

其他以 Thirona BV 為申請人之記錄

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K232412肺Q v3.0.0

相關器械（代碼：JAK）

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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