Vivo 45 LS
K-Number: K193586 · 2021-01-27
ApplicantBreas Medical AB
Decision Date2021-01-27
Product CodeNOU
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Vivo 45 LS is a medical device manufactured by Breas Medical AB. It received FDA 510(k) clearance on 2021-01-27 under approval number K193586. The device is classified under product code NOU. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Vivo 45 LS?
Vivo 45 LS is a medical device that received FDA 510(k) clearance on 2021-01-27. It is manufactured by Breas Medical AB. The 510(k) number is K193586.
When was Vivo 45 LS approved by the FDA?
Vivo 45 LS received FDA 510(k) clearance on 2021-01-27, under approval number K193586.
What company makes Vivo 45 LS?
Vivo 45 LS is manufactured by Breas Medical AB.
What is the FDA product code for Vivo 45 LS?
The FDA product code for Vivo 45 LS is NOU.
Other Devices by Breas Medical AB
Related Devices (Code: NOU)
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.