Vivio System
K-Number: K183710 · 2019-10-04
ApplicantAvicena, LLC
Decision Date2019-10-04
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Vivio System is a medical device manufactured by Avicena, LLC. It received FDA 510(k) clearance on 2019-10-04 under approval number K183710. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Vivio System?
Vivio System is a medical device that received FDA 510(k) clearance on 2019-10-04. It is manufactured by Avicena, LLC. The 510(k) number is K183710.
When was Vivio System approved by the FDA?
Vivio System received FDA 510(k) clearance on 2019-10-04, under approval number K183710.
What company makes Vivio System?
Vivio System is manufactured by Avicena, LLC.
What is the FDA product code for Vivio System?
The FDA product code for Vivio System is DQD.
Other Devices by Avicena, LLC
Related Devices (Code: DQD)
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.