MBT羅盤手HT CA軟體；MBT FAST Shuttle US IVD
K 號：K251495 · 2025-08-13
廣告
器材摘要
MBT Compass HT CA Software; MBT FAST Shuttle US IVD is the device name listed in this FDA 510(k) record. The listed applicant is Bruker Daltonics GmbH & Co. KG. It received FDA 510(k) clearance on 2025-08-13 under 510(k) number K251495. The device is classified under product code QBN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MBT Compass HT CA Software; MBT FAST Shuttle US IVD?
MBT Compass HT CA Software; MBT FAST Shuttle US IVD is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is Bruker Daltonics GmbH & Co. KG. The 510(k) number is K251495.
When did MBT Compass HT CA Software; MBT FAST Shuttle US IVD receive FDA 510(k) clearance?
MBT Compass HT CA Software; MBT FAST Shuttle US IVD received FDA 510(k) clearance on 2025-08-13, under 510(k) number K251495.
Who is the listed applicant for MBT Compass HT CA Software; MBT FAST Shuttle US IVD?
The FDA 510(k) record lists Bruker Daltonics GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MBT Compass HT CA Software; MBT FAST Shuttle US IVD?
The FDA product code for MBT Compass HT CA Software; MBT FAST Shuttle US IVD is QBN.
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。
相關器械（代碼：QBN）
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。
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。
廣告