O2Vent Optima
K-Number: K190236 · 2019-08-29
ApplicantOventus Manufacturing Pty, Ltd.
Decision Date2019-08-29
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
O2Vent Optima is a medical device manufactured by Oventus Manufacturing Pty, Ltd.. It received FDA 510(k) clearance on 2019-08-29 under approval number K190236. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the O2Vent Optima?
O2Vent Optima is a medical device that received FDA 510(k) clearance on 2019-08-29. It is manufactured by Oventus Manufacturing Pty, Ltd.. The 510(k) number is K190236.
When was O2Vent Optima approved by the FDA?
O2Vent Optima received FDA 510(k) clearance on 2019-08-29, under approval number K190236.
What company makes O2Vent Optima?
O2Vent Optima is manufactured by Oventus Manufacturing Pty, Ltd..
What is the FDA product code for O2Vent Optima?
The FDA product code for O2Vent Optima is LRK.
Other Devices by Oventus Manufacturing Pty, Ltd.
Related Devices (Code: LRK)
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.