FDA 510(k)

肺Q v3.0.0

K 號：K232412 · 2024-01-08

決定日期2024-01-08

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

LungQ v3.0.0 is the device name listed in this FDA 510(k) record. The listed applicant is Thirona BV. It received FDA 510(k) clearance on 2024-01-08 under 510(k) number K232412. 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 v3.0.0?

LungQ v3.0.0 is a medical device that received FDA 510(k) clearance on 2024-01-08. The listed applicant is Thirona BV. The 510(k) number is K232412.

When did LungQ v3.0.0 receive FDA 510(k) clearance?

LungQ v3.0.0 received FDA 510(k) clearance on 2024-01-08, under 510(k) number K232412.

Who is the listed applicant for LungQ v3.0.0?

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 v3.0.0?

The FDA product code for LungQ v3.0.0 is JAK.

其他以 Thirona BV 為申請人之記錄

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K250766肺Q 4

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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