O2VENT T
K-Number: K161832 · 2016-09-23
ApplicantOventus Manufacturing Pty, Ltd.
Decision Date2016-09-23
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
O2VENT T is a medical device manufactured by Oventus Manufacturing Pty, Ltd.. It received FDA 510(k) clearance on 2016-09-23 under approval number K161832. 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 T?
O2VENT T is a medical device that received FDA 510(k) clearance on 2016-09-23. It is manufactured by Oventus Manufacturing Pty, Ltd.. The 510(k) number is K161832.
When was O2VENT T approved by the FDA?
O2VENT T received FDA 510(k) clearance on 2016-09-23, under approval number K161832.
What company makes O2VENT T?
O2VENT T is manufactured by Oventus Manufacturing Pty, Ltd..
What is the FDA product code for O2VENT T?
The FDA product code for O2VENT T 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.