FDA 510(k)

STS 請注意，這裡的 "STS" 似乎是一個設備名稱或識別碼，並未提供完整的文檔內容，因此無法進行完整的翻譯。如果您能提供完整的文檔內容，我將能夠提供正確的翻譯。

K 號：K240293 · 2024-09-17

決定日期2024-09-17

產品代碼BZC

諮詢委員會AN

決定相當於

器材摘要

STS is the device name listed in this FDA 510(k) record. The listed applicant is Techbopulm, Ltd.. It received FDA 510(k) clearance on 2024-09-17 under 510(k) number K240293. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STS?

STS is a medical device that received FDA 510(k) clearance on 2024-09-17. The listed applicant is Techbopulm, Ltd.. The 510(k) number is K240293.

When did STS receive FDA 510(k) clearance?

STS received FDA 510(k) clearance on 2024-09-17, under 510(k) number K240293.

Who is the listed applicant for STS?

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

What is the FDA product code for STS?

The FDA product code for STS is BZC.

相關器械（代碼：BZC）

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。

K183567維恩圖斯/哨兵套件產品線Vyaire Medical K190853維恩塔斯BODYVyaire Medical, Inc.K181524Vyntus ONE 配 CART，Vyntus ONE PFT 只配 CART，Vyntus ONE 配可調節 CART，Vyntus ONE PFT 只配可調節 CARTVyaire Medical, Inc.K162515COSMED K5 穿著式代謝技術Cosmed Srl K161295MiniBox +Pulmone Advanced Medical Devices, Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

相關 PubMed 文獻

相關器械（代碼：BZC）

官方來源