Lyra
K-Number: K191372 · 2019-07-15
ApplicantInteracoustics A/S
Decision Date2019-07-15
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Lyra is a medical device manufactured by Interacoustics A/S. It received FDA 510(k) clearance on 2019-07-15 under approval number K191372. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Lyra?
Lyra is a medical device that received FDA 510(k) clearance on 2019-07-15. It is manufactured by Interacoustics A/S. The 510(k) number is K191372.
When was Lyra approved by the FDA?
Lyra received FDA 510(k) clearance on 2019-07-15, under approval number K191372.
What company makes Lyra?
Lyra is manufactured by Interacoustics A/S.
What is the FDA product code for Lyra?
The FDA product code for Lyra is EWO.
Other Devices by Interacoustics A/S
Related Devices (Code: EWO)
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.