O2Vent W
K-Number: K171316 · 2017-07-11
ApplicantOventus Manufacturing Pty, Ltd.
Decision Date2017-07-11
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
O2Vent W is a medical device manufactured by Oventus Manufacturing Pty, Ltd.. It received FDA 510(k) clearance on 2017-07-11 under approval number K171316. 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 W?
O2Vent W is a medical device that received FDA 510(k) clearance on 2017-07-11. It is manufactured by Oventus Manufacturing Pty, Ltd.. The 510(k) number is K171316.
When was O2Vent W approved by the FDA?
O2Vent W received FDA 510(k) clearance on 2017-07-11, under approval number K171316.
What company makes O2Vent W?
O2Vent W is manufactured by Oventus Manufacturing Pty, Ltd..
What is the FDA product code for O2Vent W?
The FDA product code for O2Vent W 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.