Unyvero LRT BAL Application
K-Number: K191967 · 2019-12-20
ApplicantCuretis GmbH
Decision Date2019-12-20
Product CodeQBH
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Unyvero LRT BAL Application is a medical device manufactured by Curetis GmbH. It received FDA 510(k) clearance on 2019-12-20 under approval number K191967. The device is classified under product code QBH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Curetis GmbH. The 510(k) number is K191967.
When was Unyvero LRT BAL Application approved by the FDA?
Unyvero LRT BAL Application received FDA 510(k) clearance on 2019-12-20, under approval number K191967.
What company makes Unyvero LRT BAL Application?
Unyvero LRT BAL Application is manufactured by Curetis GmbH.
What is the FDA product code for Unyvero LRT BAL Application?
The FDA product code for Unyvero LRT BAL Application is QBH.
Other Devices by Curetis GmbH
Related Devices (Code: QBH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.