FDA 510(k)

Unyvero LRT BAL 애플리케이션

K-번호: K191967 · 2019-12-20

결정일2019-12-20

제품 코드QBH

자문 위원회미 (Original text: MI)

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기기 요약

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.

자주 묻는 질문

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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