Oniris
K-Number: K150566 · 2016-03-21
ApplicantSas Oniris
Decision Date2016-03-21
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Oniris is a medical device manufactured by Sas Oniris. It received FDA 510(k) clearance on 2016-03-21 under approval number K150566. 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 Oniris?
Oniris is a medical device that received FDA 510(k) clearance on 2016-03-21. It is manufactured by Sas Oniris. The 510(k) number is K150566.
When was Oniris approved by the FDA?
Oniris received FDA 510(k) clearance on 2016-03-21, under approval number K150566.
What company makes Oniris?
Oniris is manufactured by Sas Oniris.
What is the FDA product code for Oniris?
The FDA product code for Oniris is LRK.
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.