Unyvero LRT BAL 应用程序
K号: K191967 · 2019-12-20
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申请人Curetis GmbH
决定日期2019-12-20
产品代码QBH
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决定实质等同
器械摘要
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.
常见问题
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.
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