Unyvero LRT BAL 製品申請
K 號：K191967 · 2019-12-20
廣告
器材摘要
Unyvero LRT BAL Application is the device name listed in this FDA 510(k) record. The listed applicant is Curetis GmbH. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K191967. The device is classified under product code QBH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Unyvero LRT BAL Application?
Unyvero LRT BAL Application is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Curetis GmbH. The 510(k) number is K191967.
When did Unyvero LRT BAL Application receive FDA 510(k) clearance?
Unyvero LRT BAL Application received FDA 510(k) clearance on 2019-12-20, under 510(k) number K191967.
Who is the listed applicant for Unyvero LRT BAL Application?
The FDA 510(k) record lists Curetis GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Unyvero LRT BAL Application?
The FDA product code for Unyvero LRT BAL Application is QBH.
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。
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