Oniris
K-Number: K150566 · 2016-03-21
ApplicantSas Oniris
Decision Date2016-03-21
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Oniris is the device name listed in this FDA 510(k) record. The listed applicant is Sas Oniris. It received FDA 510(k) clearance on 2016-03-21 under 510(k) 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. The listed applicant is Sas Oniris. The 510(k) number is K150566.
When did Oniris receive FDA 510(k) clearance?
Oniris received FDA 510(k) clearance on 2016-03-21, under 510(k) number K150566.
Who is the listed applicant for Oniris?
The FDA 510(k) record lists Sas Oniris as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Oniris?
The FDA product code for Oniris is LRK.
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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.