cortiQ PRO
K-Number: K191432 · 2020-01-24
ApplicantG.Tec Medical Engineering GmbH
Decision Date2020-01-24
Product CodeOLU
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
cortiQ PRO is a medical device manufactured by G.Tec Medical Engineering GmbH. It received FDA 510(k) clearance on 2020-01-24 under approval number K191432. The device is classified under product code OLU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the cortiQ PRO?
cortiQ PRO is a medical device that received FDA 510(k) clearance on 2020-01-24. It is manufactured by G.Tec Medical Engineering GmbH. The 510(k) number is K191432.
When was cortiQ PRO approved by the FDA?
cortiQ PRO received FDA 510(k) clearance on 2020-01-24, under approval number K191432.
What company makes cortiQ PRO?
cortiQ PRO is manufactured by G.Tec Medical Engineering GmbH.
What is the FDA product code for cortiQ PRO?
The FDA product code for cortiQ PRO is OLU.
Other Devices by G.Tec Medical Engineering GmbH
Related Devices (Code: OLU)
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.